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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-05-12
- Length: 51m
- Episode: 406
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-12-406-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-2
- Listen: https://podcast.greenlight.guru/episode/406-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-2

## Summary

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.

## Outline

1. Introduction: Etienne Nichols and Mike Drues on Rx to OTC Pathways
2. Submission Requirements: 510(k) vs. De Novo for Label Expansions
3. Risk Management and Usability Testing for Lay Users
4. Clinical Trials, GCPs, and Real-World Evidence vs. Data
5. Pre-Submission Meetings and FDA Feedback Strategies
6. Labeling, Cleaning, and UDI Considerations for OTC Devices
7. Digital Health and Software as a Medical Device (SaMD)

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- 510(k) (other)
- De Novo (other)
- PMA (other)
- IVD (other)
- CGM (product)
- WebMD (other)

## Related episodes from other shows

- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)
- [Etienne Nichols | How to Become a MedTech Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-03-24-etienne-nichols-how-to-become-a-medtech-engineer) (Being an Engineer)
- [127 - "If we do our job, no one will know" with LeRonda Perry](https://hardwarepodcasts.com/podcast/people-of-packaging/2022-04-27-127-if-we-do-our-job-no-one-will-know-with-leronda-perry) (People of Packaging)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-12-406-over-the-counter-otc-vs-prescription-rx-medical-devices-pt-2. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.