# What "Exempt" Means with Respect to Medical Devices & Regulatory

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-11-30
- Length: 52m
- Episode: 292
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory
- Listen: https://podcast.greenlight.guru/episode/what-exempt-means-with-respect-to-medical-devices-regulatory

## Summary

Mike Drues, President of Vascular Sciences, joins host Jon Speer of Greenlight Guru to clarify the regulatory meaning of 510(k) exemptions for medical devices. Drues explains that 'exempt' does not mean unregulated; exempt devices remain subject to general controls and quality systems, but are not subject to formal pre-market review like a 510(k) submission. The conversation distinguishes between Class I and Class II devices, noting that while most Class I devices are exempt, some Class II devices are also exempt if specific controls are sufficient. Using examples like scalpels, wheelchairs, and blood refrigerators, Drues illustrates how intended use, labeling, and technology determine classification and exemption status.

## Chapters

- [1:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=69) Introduction and Defining 'Exempt'
- [11:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=685) Classification vs. Exemption Independence
- [15:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=959) General Controls vs. Special Controls
- [23:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=1413) Strategic Use of De Novo and Special Controls
- [27:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=1662) Class I Exempt Examples: Scalpels and Wheelchairs
- [36:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=2202) Class II Exempt Examples: Blood Refrigerators
- [46:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory#t=2795) Regulatory Logic and Final Takeaways

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 13485 (other)
- ISO 14971 (other)
- G2 (other)

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## 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/2022-11-30-what-exempt-means-with-respect-to-medical-devices-regulatory. 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.