Hardware Podcasts

#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2

Global Medical Device Podcast · 12 May 2025 · 51m · Episode 406

What this episode covers

Etienne Nichols and regulatory affairs expert Mike Drues discuss the regulatory pathway for switching a medical device from prescription (Rx) to over-the-counter (OTC) status. They explain that removing the healthcare provider from the user loop typically requires a new FDA submission, such as a 510(k) or De Novo, depending on whether the device remains substantially equivalent. The conversation highlights the critical role of usability testing to mitigate lay-user error, the strategic use of real-world evidence to avoid unnecessary clinical trials, and the importance of aligning labeling and risk management with home-use scenarios.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Products
CGM
Also
FDA, 510(k), De Novo, PMA, IVD, WebMD

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