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

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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