Podcasts about vascular sciences

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about off-label communication. More specifically, we're reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed:Can you first please provide an explanation of what “off-label” is in terms of the FDA?Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?What's new in this “final” guidance?What is meant by firm-initiated communication containing scientific information on unapproved uses?If you communicate with an organization about unapproved (or off-label) uses, what will happen?If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?Does FDA need to know about the communication?What else is important?What are the most important takeaways?Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this discussion. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're continuing our conversation on off-label communication. In this part, we're examining the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed:Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.Now getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what's potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?Do you have any examples you can share?Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don't need to be?What happens when a company makes unsupported, deceptive, or completely false claims about a product?In your professional opinion, should we allow a company to advertise unapproved claims that haven't gone through a formal review process? Is it a good thing or a bad thing?What else is important?What are the most important takeaways?Listen to this discussion after you've heard Part 1 and see what you think of off-label communication and the guidance. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing over-the-counter (OTC) devices and aspects developers need to keep in mind for these devices. A variety of topics are covered, from regulatory questions to human factors design to cleaning protocols. Real-world examples are used to help illustrate several discussion topics. Specifically, the following questions are addressed:What is an OTC device and how do OTC devices compare to prescriptive devices?Can you provide some examples of OTC devices?What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?Does a switch from Rx to OTC for a 510(k)-cleared device require a new premarket submission?Can real-world evidence (RWE) be used to support a premarket submission for an OTC device, including a switch from Rx to OTC use?After you listen to this discussion, move on to part 2 to gain more specific insights as we narrow down on particular factors. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're continuing our conversation about over-the-counter (OTC) medical devices. If you haven't already enjoyed part 1 of the discussion, please be sure to listen to that one first. In this segment, we look at more specific regulatory- and design-related questions that could create some misunderstanding or confusion. Specifically, the following questions are addressed:What is the process for bringing a novel OTC device to market?Under what circumstances would a switch from Rx to OTC require a De Novo or premarket approval application (PMA) in lieu of a 510(k) submission?What considerations may be relevant when designing an OTC device?What is the mechanism for obtaining feedback from the FDA on the necessary data to support a premarket submission for an OTC device??What are the requirements for clinical trials of OTC devices?What is the role of human factors testing for OTC devices?What are the labeling considerations for OTC devices?What are the cleaning or disinfection considerations for OTC devices?What are the Unique Device Identifier (UDI) requirements for OTC devices?What else is important?Are OTC devices searchable in the FDA's medical device databases?When are OTC digital health solutions or software regulated as devices?What considerations apply to OTC software devices or connected devices?What are todays take-aways?After listening to both parts of the discussion, do you have a better understanding of OTC devices and are you evaluating your own products to see if any should be considered for this expansion? If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing a common part of a regulatory submission—the device description. While this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews the role this section plays in a regulatory submission and common mistakes that occur are covered. Specifically, the following questions are addressed:Of all the potential topics we could be covering, why has device descriptions come up as one we should discuss?What support do you have to say device descriptions are one of the most poorly written sections of a pre-sub or final regulatory submission?What is the point of the device description in a regulatory submission? Why would it be so important to get it right?How can you verify your device description does its job? How do you know?How do you balance technical detail with simplicity in a device description, especially when you're describing a complex device?Is it worthwhile to reiterate the device description in a pre-sub meeting? Shouldn't the reviewers already be familiar with it if it was included in the pre-sub submission.Can you share specific recommendations on how to best write or design a device description?Do you have an example you can share?What else is important and/or what should listeners take away from this episode?Listen to this discussion and see if you think you may have submitted device descriptions incorrectly in the past. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring themes that are not exclusive to the election, such as the impact of regulatory on innovation. Specifically, the following questions are addressed:Based on the fact things can continue to change, why discuss this now?Would it be possible to eliminate the FDA? What might replace it?Is there too much regulation of medical devices? Or is it just the opposite—too little? What's the sweet spot?There are some who believe the more regulation we have, the less innovation that's possible. Do you agree? Are these directly impacted by each other?Is it possible to separate regulation and politics?Other than AdvaMed, which said it was looking forward to working with the new administration for what that's worth, why isn't the FDA or industry speaking about the possible eliminations at FDA?Do you agree that safety and efficacy should NOT be a function of politics?Without naming specific people, who is the type of person you'd want heading HHS or the FDA?Does this discussion have implications related to reimbursement or CMS?If you were serving as a regulatory consultant for a company looking at what's potentially coming down the road, how would you advise them today?Any final thoughts on what's important for this discussion/topic?Listen to this discussion and see if you agree with our assessments. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want toSend us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're drawing inspiration from an item I wrote about recently in one of my MPO editor's letters. Specifically, I'm referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted suicide is legal under certain conditions. However, following the first instance of someone successfully using the device within the country, several people involved were arrested and the situation is being investigated further. Specifically, the following questions are addressed:Should this be a device that goes through a regulatory review? Given its purpose, should it be treated as a regulated device?If it were a regulated medical device, what would its classification be?What would be its pathway to market?Does risk have the same definition for a device like this?Similarly, what about safety and efficacy? Is testing or a clinical trial required or even appropriate?Is there a precedent for this type of product? Not talking about a predicate here but a precedent.Any final thoughts on what's important for this discussion/topic?Listen to this discussion and see if you have a better understanding of CAPAs. If you'd like to share thoughts, ask questions, or have a suggestionSend us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA's recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier podcast on this topic). The more recent guidance expands the scope to any medical device, whether it has AI/ML or not. Specifically, the following questions are addressed:What is a predetermined change control plan and why is it important?FDA published two guidances on PCCPs (one last year in April and one just this past August). These two guidances sound similar (maybe substantially equivalent), so what's the difference?What's the difference between a PCCP for a SaMD with ML or AI different from a PCCP for a non-SaMD device, like a catheter or stent?Are there any limits on changes in a PCCP?How and when do I submit a PCCP?What are the advantages of submitting a PCCP?Are there any disadvantages of submitting a PCCP?Listen to part 2 of this discussion and then see if you have a better understanding of PCCPs. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven't yet listened to Part 1, click here to do so. Specifically, the following questions are addressed in part 2:You have submitted a PCCP with a previous regulatory submission, but you have not yet made the actual, real-world change to the device. Can that PCCP submission, assuming it was approved, be used as a predicate for a 510k submission?For what types of devices should I consider a PCCP?Can you provide a few examples of PCCPs?Can PCCPs be used for manufacturing?Since the use of a PCCP is relatively new, can you think of what questions could potentially arise? What questions might we not have just yet?Anything else you'd like to say about the use of a PCCP we haven't covered?What are the important takeaways?After both parts, do you have a better understanding of PCCPs? If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're focusing in on a regulatory piece that's been mentioned numerous times with regard to other topics we've discussed. This episode is focused on CAPA or corrective and preventive action. We're digging into the CAPA, what it is, its purpose, and how to best implement it. Specifically, the following questions are addressed:Could you please briefly highlight the reasons FDA issues 483 observations and warning letters?What is a CAPA and when should it be used?What are the most common reasons for 483s and warning letters involving a CAPA?How do you know if your CAPA is doing what it's supposed to do?Is industry taking the wrong approach with a CAPA? Is there a better way we could be looking at this issue?How are CAPAs related to other aspects of the QMS, such as risk, post-market surveillance, or complaint handling?Do you have examples that might help illustrate what we've discussed?What else is important and/or what are the most important takeaways?Listen to this discussion and see if you have a better understanding of CAPAs. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed:Could you please explain what a 483 is and what a warning letter is? Are they the same thing?What are some common reasons or examples of why a company would get a 483 or warning letter?What are the first steps for a company that has just received a warning letter or 483?Who is responsible for the response to a 483 or warning letter? Does this fall to regulatory? Quality? Who really should be responsible for addressing it?Is it common for a company to get a warning letter or 483 for the same issue? If that happens, what then should the company do?What's worse than a 483 or warning letter? Is there a higher level that really causes a concern for the company involved?What should be considered in terms of the PR hit as a result of a 483 or warning letter?Do you have suggestions with regard to preventing a 483 or warning letter?Anything more a company should consider and after that, please share what you consider to be the most important takeaways?Listen to this discussion and see if you have a better handle on what to do if you get a 483 or warning letter. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a Text Message.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're revisiting real-world evidence (RWE), which is a topic that's been getting some attention. So today, we're going to look at what's driving that attention and discuss the reasons behind it. We'll also talk about how the FDA is seeking to use real-world evidence. Specifically, the following questions are addressed:We've discussed real-world evidence previously, in podcasts from 2017 and 2020, but what's the cause for us to do so today?Without requiring people to go back and relisten to those previous podcasts—not that I'd object—can you please briefly explain what real-world evidence is? Could you also mention how it compares and contrasts with real-world data?How does real-world evidence compare to what's deemed the gold standard—randomized clinical trials?Do you have any examples of how real-world evidence has been used in regulatory submissions?FDA has a new draft guidance around real-world evidence. What's actually new in this?In your estimation, what are the limitations of the new guidance? Is it falling short of what its goal should be or is supposed to be?Does the real-world data or evidence need to come from use within the U.S.?In discussing the possibility of doing this topic, you mentioned manufacturers may be missing a real opportunity with real-world evidence. What do you mean by that?What are the takeaways?Listen to this discussion and see what you think of the use of real-world evidence. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documentary, The Bleeding Edge, was discussed but others are new. Specifically, the following questions are addressed:First Mike, can you provide a definition of what a dangerous device is?As I mentioned in the introduction, we previously discussed the 2018 documentary The Bleeding Edge, which featured some dangerous devices. How far back do dangerous devices go though? Are these a relatively newer problem?Another publisher's website featured a slideshow of four dangerous devices. But do you have any sort of idea of how many others there may have been?With all the regulations in place, regulatory professionals that work in this industry, and FDA oversight, how do any “dangerous devices” make it to the market?Should we be adding regulations to address these devices so they don't happen again?What are the takeaways?Listen to this discussion and see what you think of the system we have to attempt to prevent these types of devices from getting to market. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:Can you give some additional insights into each of these news items and explain how they are connected?Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?If a basic device like a syringe cracks or doesn't function properly, how realistic is it that the issue is reported to the manufacturer or FDA?If my device includes a syringe but it's not manufactured by one of the companies that received a warning letter (or maybe it's not even made in China), do I have anything to worry about?Do you have an example to help illustrate this?Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?What are the takeaways?Listen to this discussion and see what you think of these concerns regarding device safety. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're looking at the latest annual list put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization's website, which is at www.ecri.org. Specifically, the following questions are addressed:What is ECRI and what is the purpose of this list?Number one on the list is medical devices for the home. Specifically, they indicate medical devices may pose usability challenges for home users, risking misuse and patient harm. Can you please explain why this would be number one on the list? What's the issue with usability?The second item on the list involves inadequate or onerous device cleaning instructions. So this isn't really about cleaning protocols, but rather the instructions that indicate how the device should be cleaned. What's the concern here?The fourth item is regarding the sustainability trend. Specifically, ECRI states this one as overlooked environmental impacts of patient care endanger public health. This is more of a product design issue, correct?Another hot topic item, number five calls out insufficient governance of AI used in medical technologies risks inappropriate care decisions. Is this indicating we should avoid relying too heavily on decisions indicated by AI and ensure clinician overview of findings?Still another hot button, cybersecurity issues ranks at number six on the list. Specifically, it is listed as ransomware targeting the healthcare sector remains a critical threat. This ties in directly to the significant efforts being put forth to ensure connected devices have a cybersecurity plan in place, correct?What are the takeaways?Listen to this discussion and see what you think of these items on the list or what was missed and should have been on the list. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're looking at IRBs, or institutional review boards. We're taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:Could you please explain what an IRB or institutional review board is?If I'm a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?Are there situations in which I would not need an IRB approval prior to a clinical trial?Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I'd want to avoid?What information do I need to provide to the IRB for its review?What kind of timeline should I expect with the IRB review process?Do I have any recourse if the IRB review comes back not in my favor?What are the takeaways?Listen to this discussion and see if you've gained insight for your next interaction with an IRB. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that's occurred with regard to getting reimbursement tied to the FDA's Breakthrough Designation Program (BDP). It's been planned, called off by CMS, put into proposed legislation, but we still don't have a definitive solution. Specifically, the following questions are addressed:Can you please explain what the Breakthrough Device Designation program is?When did the reimbursement component come into play with regard to the BDP?Why is it important for a BDP device to have reimbursement tied to it upon regulatory approval/clearance?What concerns did CMS have regarding the reimbursement portion of the BDP?This year, we've seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What's going on with these?Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?What about the proposed “reasonable and necessary” caveat that's also associated with the TCET? Do we need to clarify what this means or just replace it entirely?What are the takeaways?Listen to this discussion and see how you feel about the latest proposed reimbursement plan. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:Can you please provide a brief explanation of the 510k pathway?Why is the agency attempting to strengthen the program? What is their ultimate goal?With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?What other best practices are tied to the predicate device selection?How do you gather clinical data on a device that's not cleared or approved and just being submitted to the FDA?For what situations is the agency considering clinical data in a submission and why?For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?What do these mean to you? What will they mean to medical device manufacturers?What are the takeaways?Listen to this discussion and let us know what you think of any or all of these guidances. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?Medical device recalls aren't new, so why are we taking a closer look at them today?Should we have been able to see this coming? Was this foreseeable?Are all of these recalls, or really any recalls, equal in terms of how serious they are?Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it's not being recognized?Who's job is it to set the specs?Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?What are the takeaways?Listen to this discussion and see if you feel more comfortable about avoiding a recall. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:Can you please give a brief overview of what an AI or ML product is?Can you explain how this product can, quote evolve, as the FDA puts it?Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?So why is this important? Why is it important to enable an AI or ML device to evolve?Can you offer real world examples of how this all works?What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)What are some of the specific items a PCCP should include?Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?Quotes"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike DruesReference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed:First, would you please explain the various levels of a recall as it relates to a medical device and what each level means?Can you quickly remind us of how a predicate device is used in a 510k submission?Given we've laid the groundwork, can you now please explain how a recalled device can be used as a predicate device?Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?What are the most important takeaways?Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

When bringing a medical device to the market, it's important to be aware of the fatal 510(k) flaw. In today's episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today's conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate. Some of the highlights of this episode include:What happens when the predicate that you'd like to use for your 510(k) has undergone a Class 1 recallThe risk management element of using a predicate that's undergone a Class 1 recallThe statistics about recall predicates used in 510(k)sHow the way the 510(k) is used has changed since it was first createdWhy the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recallSolving the problem of a predicate that's been through multiple recallsConsidering competitor's products or other products similar to the one yours is based onWhat post-market surveillance should entailThe direct and indirect economic impact of a Class 1 recallChanges that may happen with the FDA in the futureMemorable quotes from Mike Drues:“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that's undergone a recall.”“Unfortunately, good news does not sell. Bad news sells.”Links:Mike DruesVascular Sciences510(k) GuidanceJAMA Study 1JAMA Study 2FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare YoursUltimate Guide to Postmarket Surveillance of Medical DevicesEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that's the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed:Can run through the top reasons for 483s and warning letters?Can you provide some examples of CAPA problems and offer suggestions for avoiding them?Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?Are these top three problems really identical to what we've seen in previous years? Are these the same mistakes again?What are the most important takeaways with regard to today's discussion?Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

Why do the same types of problems show up again and again in FDA medical device inspections? In today's episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.Some of the highlights of this episode include:Common reasons why companies get in trouble during FDA inspectionsWhy CAPA is specifically at the top of reasons for 483s and how to prevent thatExamples of design control problems and how to avoid themThe root causes of these issues and root cause analysisWhat complaint handling problems look likeWhat causes people not to handle complaints correctlyWhether anything about these problems is new or trendingWhat the FDA does when they find these problemsMemorable quotes from Mike Drues:“The emphasis should be on prevention, not correction.”“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you're doing.” “What is the point of getting complaints or post-market surveillance or anything else if you're not going to act on it?”“I hate to say it, but we are the poster children for Einstein's definition of insanity.”Links:Mike Drues LinkedInVascular SciencesEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today's episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they're ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I'm a biomedical engineer first and a regulatory consultant second. And that's the order we should think about these things.”“Even though I'm a regulatory consultant, I'm not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What's the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today's episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn't regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it's developed.”“If the hospital does one thing, they're treated one way; if a company does exactly the same thing, they're treated another way. Something's not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today's episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.Today's conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. In this episode, you'll hear what Mike has to say about what's on the FDA's A-list and B-list for the fiscal year 2023, what isn't on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines. Some of the highlights of this episode include:What the CDRH proposed guidelines for fiscal year 2023 are about and why it's important to think about themThings that stick out on the FDA's A-list of guidelinesItems that are surprising or exciting on the A-listWhat is on the FDA's B-list of guidelinesWhat's missing from the A-list or the B-listHow collective wisdom is shared across various organizationsWhether the FDA should be giving guidance to help companies get products to marketThe difference between draft guidance and final guidanceIdentifying changes between versions of guidelinesWhether you have to do something if it's in the guidelinesMemorable quotes from Mike Drues:“Not to be too arrogant here, but I'm very proud of the fact many of the things that I've done in submissions over the years, whether it's with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”“That's why there's a guidance document database, so you and I don't have to memorize such esoteric trivia.”“It's really not FDA's job to help a company bring a product on the market.”“All guidance, indeed all regulation, is very evolutionary. It's a work in progress.”Links:Mike Drues LinkedInFDA Website: CDRH Proposed Guidance's for Fiscal Year 2023RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today's discussion with guest, Mike Drues.Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now. Some of the highlights of this episode include:What an EUA is, and when it's usedAn EUA as a pathway to marketWhat the COVID experience has taught us about EUAWhether FDA reviews are back to normalThe poor quality of some EUA submissionsQuality requirements for EUA vs. non-EUA devicesWhat's new in EUAs beyond COVIDMonkeypox EUA developmentsImprovements in EUA qualities as submissions continueTop takeaways from today's discussionMemorable quotes from Mike Drues:“One of the things I've learned in playing this game now for about 30 years is most problems that companies get into, not only are they preventable, they're predictable.”“As a matter of fact, FDA estimates that 80% of submissions, 80% of EUA submissions, needed revisions, needed additional information.” “If you have experience doing these things, you're going to be more successful. If you don't have experience doing these things, that's not a problem; you can't be an expert at everything, but get somebody to help you.” “Don't treat FDA as our elementary school teacher.” Links:Mike Drues LinkedInArticle: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) ReportCDRH Website: Monkeypox Emergency Use Authorizations for Medical DevicesArticle: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicFDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyFDA Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic? Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 hereMike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 hereEmergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know (GreenLight.Guru, April, 2020)Podcast: Tips For Being Prepared Post-EUA (January, 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA's emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed:Could you please explain what an EUA is within the regulatory context of the pandemic?Under whose authority is the pandemic deemed over such that the status of devices on the market under EUAs become a concern?How will the FDA handle these EUA products?What should companies be doing now if they want to keep their products on the market after the EUAs expire?Are there any considerations companies should keep in mind with an EUA product?Are there any reasons a company may not want an EUA product to go through a full regulatory review?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see if the end of EUAs impacts your company. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don't qualify for exemption and how that intersects with how a device is classed?This is the focus of today's episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don't intersect with exemptions, and why some items are exempt.Some of the highlights of this episode include:The meaning of 510(k) exemptWhy “exempt” may not be the best wordWhat unregulated medical devices are calledClassifications don't necessarily mean that a device is exemptComparing and contrasting Class I and Class IIThe difference between general controls and special controlsExamples of exemptions and why they're exemptThe shades of gray in regulationThe regulatory logicMemorable quotes from Mike Drues:“An exempt device, whether it's a Class I exempt or a Class II exempt device, it doesn't matter, is still a regulated medical device.”“Instead of calling these special controls, we should call them specific controls.”“One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?”“What is much much more important than the answer is the logic you use to get the answer.”Links:Mike Drues LinkedInCDRH Website: Class I and Class II Device ExemptionsList of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP RequirementsWebinar: When do we need FDA's permission to market our device and when do we not? (Nov 2020)Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)Webinar: Understanding the Medical Device Classification System (July 2020)Webinar: General Wellness Devices and Wearables (May, 2018)Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:Could you please explain what 510k exempt actually means?Are all Class I medical devices exempt and all Class II devices not exempt?What's the difference between Class I exempt and Class II exempt?What is the difference between general controls and special controls? How are these relevant to exempt status?Could you give some examples of products that are Class I exempt and explain why they are afforded that status?Now could you do the same for Class II products that are exempt and give reasons why?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how 510k exempt may affect your company's products and future regulatory submissions. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn't? Those are the questions that today's guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of this episode include:What regulatory strategy is and what it isn'tWhy a good regulatory strategy is so importantWhat competitive regulatory strategy isThe mistake of focusing on only one companyHow the EU MDR is affecting regulatory strategyWhat causes delays in complying with regulationsThe industry record on post-market surveillanceReimbursement and regulatory strategyMemorable quotes from Mike Drues:“Let's not forget my old friend, competitive regulatory strategy.”“It's never too soon, in my opinion, to start thinking about regulatory strategy.”“As a general rule, we have done an abysmal job on post-market surveillance across the board.”“I consider this whole thing to be a poker game, in every sense of the word.”Links:Mike Drues LinkedInHow to Construct an Effective Regulatory Strategy Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?Can you speak to the relationship between intended use and off-label use?When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?Can you share a couple real-world examples of acceptable off-label promotion?Where is the cut-off? In other words, what should companies be sure they AREN'T doing with regard to off-label promotion?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see if you're able to promote an off-label use of one of your devices. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?How can labeling, both high level and low level, be used as a strategic advantage?Could you please explain the difference between intended use and indications for use?What is this intended use rule and why is it important to medical device manufacturers?What is meant by manufacturer's objective intent?Do you have examples you can provide?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how Intended Use affects your device labeling. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA's regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:Would you please explain what we mean by Special Controls? What are they, and how and when are they used?What makes these “special”?Would you mind providing some real-world examples of Special Controls?How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?With regard to Special Controls, what are the most important takeaways to keep in mind?Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:Please start with an explanation of the FDA's review process. What happens after the agency receives a submission?This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?What was the agency's goal in releasing these guidance documents?Do you have examples you can share of submissions rejected on RTA review?The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?How should a medical device manufacturer view these documents and how should they use them?What are the options for a device maker upon the rejection of a submission?What are today's takeaways with regard to Refuse to Accept guidance from the FDA?Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA's involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:Can you start by explaining what a voluntary recall is and why or when it's used?Is there any differences in the process for a voluntary recall across any of FDA's categories, such as pharma, medical device, food, etc.?Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?What are the steps in a voluntary recall?Is the FDA involved in a voluntary recall beyond being notified? If so, how?How do you ensure everyone who needs to be contacted about a recall is reached?What are the most important takeaways companies need to keep in mind about voluntary recalls?Listen to this episode and see if you better understand voluntary recalls. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it's appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:While we've mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?Why is a letter to file important?When does a medical device company submit a letter to file to the FDA?Does the FDA provide any guidance on a letter to file or offer a template to use for it?What goes into a Letter to file?Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?Are there situations where using a letter to file could result in an adverse effect to what was intended?When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?Listen to this episode and see if you better understand the point of the letter to file and when to use it. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.Some of the highlights of this episode include:Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It's important to understand the difference between indications for and intended use.Mistake #2 - Not Using Checklist: The FDA's 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is going to do and what it wants, so there should be no surprises.Mistake #3 - Not Providing All Expected Testing: The FDA rarely accepts promissory commitments to do sterilization, validation, or biocompatibility testing later. Also, you should include protocols, results, and reports to verify rigorousness of testing.Mistake #4 - Not Doing Real-time Shelf-life Studies: FDA wants evidence to back up claims of stated shelf life and wants a correlation between real-time and accelerated aging data. Shelf life is what happens to your product in the future.Mistake #5 - Underestimating Risk Management Requirements: Show list of requirements and provide the paper trail for your traceability. The FDA needs to conclude that your product is safe and substantially equivalent to a predicate.Mistake #6 - Not Demonstrating Equivalence with Predicates: You need to depict your device as novel and unique, but not so different that the FDA thinks your predicate is not a good example.Mistake #7 - Formatting Submission Incorrectly: Include page numbers and an eCopy. Also, the size of the file matters and needs to be named according to conventions.Memorable quotes from this episode:“The intended use statement is a pretty important premise for any 510(k) submission because for all intents and purposes, that statement helps regulators and helps you determine how your product is ultimately going to be classified.” Jon Speer“One of the most common reasons why they are rejected is because the high-level labeling when it is repeated is not repeated exactly the same way.” Mike Drues“Intended use focuses on the device. Whereas, indications for use focuses on the patient.” Mike Drues“The RTA checklist was intended to be a tool for the FDA reviewer, when submission received, for them to go through and make sure all the constituent parts and components and what is expected to be in that submission is included.” Jon Speer“FDA reviewers see probably dozens, maybe hundreds of submissions in a finite period of time. Some are better than others. Well, make yours standout. Make yours easier to read.” Jon SpeerLinks:7 Common Mistakes That Sink FDA 510(k) ClearanceFDA - 510(k) Submission Process7 FDA Pathways to Bring Your Medical Device to MarketCenter for Devices and Radiological Health (CDRH)ISO 14971Mike Drues on LinkedInVascular SciencesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company's CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?Some of the highlights of this episode include:Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA's as an opportunity to improve a product and prevent problems in the future. People do not follow procedures because sometimes they don't even know that procedures exist, or those procedures are not updated/revised after events.Memorable quotes from this episode:“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer “People don't focus on the common sensical understanding.” Mike Drues “Unless regulation makes sense, I don't care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike DruesLinks:FDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Observations and Warning LettersFDA - Medical Device OverviewInternational Medical Device Regulators Forum (IMDRF)ISO 13485 CAPA21 CFR Part 820Mike Drues on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru MedTech Lifecycle Excellence

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who's to blame? Learn from other people's mistakes. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA's Refusal to Accept (RTA) policy and guidance. Some of the highlights of this episode include:After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.If a submission is rejected on the administrative review, it is completely the company's fault, not the FDA's. If the substantive review is rejected, however, there's room for negotiation with the FDA.Most of the FDA's acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It's a company's responsibility to make sure the FDA understands their device.The draft guidance documents have been published for a reason - don't ignore them and risk a rejection for what could easily have been avoided. Memorable quotes from this episode:“If a submission gets rejected on an administrative review, that is 100% the company's fault, it is not FDA's fault.” Mike Drues“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike DruesLinks:How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)Guidance: Refuse to Accept (RTA) Policy for 510(k)sGuidance: Acceptance Review for De Novo Classification RequestsGuidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)Acceptance Checklists for 510(k)sMedical Device User Fee Amendments (MDUFA)FDA - Voluntary eSTAR ProgramWhat is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA's approach to whether or not this technology should be regulated?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. Some of the highlights of this episode include:Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.Memorable quotes from this episode:“There's been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues“The phrase, ‘additive manufacturing,' comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer“There's two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues“The blending of tech and med device, it's scary on one hand, but it can be exciting, as well. I'm looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon SpeerLinks:FDA - 3D Printing of Medical DevicesFDA - Technical Considerations for Additive Manufactured Medical Devices GuidanceFDA's Role in 3D PrintingFDA - Process of 3D Printing Medical DevicesFDA - 3D Printing Medical Devices at the Point of Care: Discussion PaperFDA - Classify Your Medical DeviceFDA - The 3Rs of 3D Printing: FDA's RolePART 820 - Quality System Regulation (QSR)Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that's the way to do something.Memorable quotes from this episode:“They are not going to adopt ISO or any other standards across the board. They'll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues“Good regulation is timeless.” George Zack“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George ZackLinks:ANSI/AAMI/ISO 13485:2016 HandbookNIST's "ABC's of Conformity Assessment"International Medical Device Regulators Forum (IMDRF)ISO 13485:201621 CFR Part 820 - Quality System RegulationFDA - Design Control Guidance for Medical Device ManufacturersFDA - Case for Quality ProgramFDA - Medical Device Single Audit Program (MDSAP)European Union Medical Device Regulation and In Vitro Diagnostic Regulation (EU MDR and IVDR)Mike Drues of Vascular Sciences on LinkedInGeorge Zack of Two Harbors Consulting on LinkedInTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!Jon and Mike share tips on what you can do to improve upon your medical device company's quality philosophy to ensure that true quality becomes a part of your company's culture.Some of the highlights of this episode include:Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality' means and whether what you're doing is good or bad.Quality management systems (QMS) shouldn't emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.Memorable quotes from this episode:“The problem I have with that simple explanation is there's subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer“For quality to be meaningful, it's something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer Links:A Regulatory Gap Analysis of FDA's Systems & PoliciesUltimate Guide to 21 CFR Part 820ISO 13485FDA - Classify Your Medical DeviceFDA - Premarket Notification 510(k)FDA - De Novo Classification RequestFDA - Premarket Approval (PMA)Mike Drues on LinkedInThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What's missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.Some of the highlights of this episode include:Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.The FDA's 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.The biggest problem with 510(k) is predicate creep. There's room for improvement because the 510(k) is the workhorse of the medical device industry.Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device."Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. Memorable quotes from Mike Drues:“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”“As we all know, the 510(k) is the workhorse of the medical device industry.”“I'm a huge advocate of communication with the FDA.”“We have tons of regulation already. We don't need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”Links:FDA - Corrective Action/Preventative Action (CAPA)FDA - Overview of Device RegulationFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - General WellnessFDA - Case for QualityFDA - Warning LettersFDA - Form 483 FAQFDA - De Novo Classification RequestFDA - Emergency Use Authorization (EUA)FDA - Breakthrough Devices Program (BDP)FDA - Safer Technologies Program (STeP) for Medical DevicesFDA - Custom Device Exemption (CDE)Centers for Medicare and Medicaid Services (CMS)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.Some of the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don't work? Both the regulatory and quality burden is higher for companies in the medical device industry.Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. Don't waste the FDA's time. The EUA needs to be a part of a company's overall regulatory strategy to determine how it fits into the bigger picture.Memorable quotes from this episode:“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there's things that you should be doing and frankly you should have already been doing them.” Jon Speer “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues “Basically, it's a very, very special kind of pathway. It is not an approval. It is not a clearance. It's an authorization.” Mike Drues “If you're not building a plan, a strategy, and starting to execute that strategy, you're going to be leaving the market with your products.” Jon SpeerLinks:FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?The End of EUA Is Coming SoonFDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

At the top of the FDA's agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.The FDA's Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA's list of priorities to be finalized in 2022. Some of the highlights of this episode include:According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies' products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.Regulated or not, usability testing is a must. What if your software tells patients they don't have a problem, but actually do, and wait to take care of it? Memorable quotes from Mike Drues:“I've got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”“Right now, much of this is not being regulated by the FDA. The FDA - they're using their enforcement discretion to not regulate.”“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.” “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”Links:Clinical decision support guidance tops FDA's agenda for 2022 (Med City News) (Oct. 29, 2021)FDA's 2022 A-list guidance plan hits on software, post-pandemic futureCDRH Guidance: Clinical Decision Support Software (September 2019)FDA - Medical DevicesSoftware as a Medical Device (SaMD)Combination Products Webinarhttps://www.greenlight.guru/webinar/combination-productsGeneral Wellness Device and Wearable Exemption WebinarWebMDMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru