• 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 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 [email protected] 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.

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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 [email protected] and we’ll see if we want to

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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 suggestion

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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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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For more medtech news and information, visit www.mpomag.com.