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 sfenske@rodmanmedia.com 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 sfenske@rodmanmedia.com and

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