Development Considerations for OTC Medtech, Part 2

Medtech Matters

• 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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