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Development Considerations for Over-the-Counter Medtech, Part 1
Manage episode 462782922 series 2805302
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.
For more medtech news and information, visit https://www.mpomag.com.
152 قسمت
Manage episode 462782922 series 2805302
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.
For more medtech news and information, visit https://www.mpomag.com.
152 قسمت
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