Development Considerations for Over-the-Counter Medtech, Part 1

Medtech Matters

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5M ago 47:21

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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 sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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