Hardware Podcasts

#405: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1

Global Medical Device Podcast · 5 May 2025 · 40m · Episode 405

What this episode covers

Regulatory strategist Dr. Mike Drues of Vascular Sciences explains the regulatory distinctions between prescription (Rx) and over-the-counter (OTC) medical devices, emphasizing that OTC status depends on intended user, environment, and risk rather than just device class. He highlights label expansion strategies, citing CPAP machines and continuous glucose monitors (CGMs) as examples of devices moving from Rx to OTC, and discusses the critical importance of usability testing that reflects diverse patient populations rather than just healthcare professionals. Dr. Drues also addresses the misconception that home-use devices are automatically safe or OTC, noting that many Rx devices are used at home, and outlines the characteristics required for OTC status, including self-diagnosis, self-selection, and low potential for misuse.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, Philips, Levels, CVS, Walgreens
Products
CPAP, continuous glucose monitors, Dexcom
Also
FDA

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