In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:

• As most are already familiar with QMS and now QMSR, we’ll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?
• Is a full QMS required to be in place in order to secure FDA clearance or approval?
• What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?
• When do I need to have a QMS in place?
• What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.
• Should all QMS systems look the same?
• Are there differences with the QMSR with premarket vs. postmarket?
• How do you know the QMS is working? How can you be sure?
• What are the important takeaways from today’s session?

Listen to this discussion and see if you are compliant with the new QMSR. 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 your ideas/inquiries/suggestions align with a future episode.

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In this Medtech Matters podcast episode, sponsored by Nelson Labs, we’re discussing the importance of E&L (extractables and leachables) and biocompatibility testing for a variety of medical devices. The pair from Nelson Labs—Audrey Turley, B.S., Director of Lab Operations – Biosafety, and Kristin Treece, Ph.D., Principal Scientist - Analytical Chemistry—bring their expertise to the conversation, where a number of issues are resolved. During this episode, the following questions are addressed:

• First, what is Nelson Labs? What do you do? 
• What is E&L testing?
• Why is it important? 
• What is being tested? 
• Is this done on all medical devices?
• Are there different tests for E&L depending on the device and/or application?
• When is E&L testing performed?
• What is biocomp testing? 
• Why is it important?
• When is it performed?
• How do you perform in vivo testing? (and what does in vivo mean?)
• Anything else device manufacturers need to know about E&L and/or biocomp testing?

Listen to this discussion and see if you still have questions about E&L and/or biocompatibility testing. If you do, reach out to Nelson Labs to get answers. Feel free to use the links or contact mechanism here.

Click here to learn more about Nelson Labs >>>>>

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the following questions are addressed:

• First, can you please explain what is out-of-bounds? (i.e., What will we NOT talk about?)
• What can FDA do during the shutdown?
• If a company currently has a submission under review, pending communications (e.g., emails, questions, pre-submission meetings), or other activities currently pending with the Agency, what would you advise the company to do? How should they proceed?
• If a company plans to make a submission, request a pre-submission meeting, or engage with FDA about other activities in the near future (but has not done so yet), what would you advise the company to do? How should they proceed?
• Can a company submit a pre-sub request during this shutdown?
• From a public policy perspective, how could situations like these be mitigated or possibly prevented in the future?
• What additional thoughts/questions/comments/concerns/recommendations/etc. do you think are important to share regarding the shutdown and its implications on medical device companies in particular and regulatory affairs in general?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you can take action during the shutdown. 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 speaking about a recent Editor’s Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the following questions are addressed:

• My editorial is about wellness products. Before discussing further, can you remind us what a wellness product is?
• Why did you write this column and given wellness devices have been “formally recognized” by FDA since 2016, why did you write it now?
• In your title, you use Wellness Products vs. Wellness Devices. Why?
• You point out in your editorial that general wellness devices are low risk devices. In fact, that’s part of the title of the guidance. But is it correct to say, “General wellness devices are low-risk devices”?
• Let’s discuss the example from my editorial (SaltAir by Halosense).
• Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer's responsibility to research and find out more about the product on their own?
• If a disclaimer is recommended (maybe not required), what should the disclaimer say?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you think wellness products should get a warning. If you’

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During this conversation, the following questions are addressed:

• Recently, three medical device senior operations officers from FDA’s Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?
• In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?
• Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?
• Can you provide some examples?
• How can design change and design creep get companies in trouble with FDA?
• What does “marketing beyond authorized intended use” mean?
• Do you have suggestions and/or best practices to avoid running into problems around these issues?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you've run into these issues yourself. 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

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed:

• First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.
• What are the MAUDE reporting requirements?
• How well does the MAUDE reporting system work?
• Are there consequences for a delayed or incomplete report?
• Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?
• What should manufacturers do?
• What should the FDA do?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. 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 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 [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 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 [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 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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