# Examining the HHS Proposal for Premarket Notification Exemptions

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-06-07
- Length: 37m
- Episode: 211
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions
- Listen: https://podcast.greenlight.guru/episode/examining-the-hhs-proposal-for-premarket-notification-exemptions

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to critique the HHS proposal to exempt over 80 device types, including exam gloves, thermometers, infusion pumps, and ventilators, from 510(k) requirements. Drues argues that lumping simple PPE with life-sustaining devices like ventilators ignores critical safety distinctions and bypasses necessary FDA consultation. He emphasizes that regulatory science must begin with biology and engineering rather than paperwork, warning that down-classifying complex devices without rigorous review compromises patient safety and competitive integrity.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=0) Introduction: HHS Proposal Overview
- [2:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=179) HHS Declassification Without FDA Consultation
- [6:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=392) Lumping Simple PPE with Life-Sustaining Devices
- [10:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=629) Irony of Regulatory Change Management
- [13:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=801) Competitive Advantage vs. Safety Concerns
- [17:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=1064) Biology and Engineering Before Regulation
- [23:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=1420) Defining Regulatory Science and PMA Review Times
- [34:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions#t=2045) Case-by-Case Review Recommendation

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- HHS (other)
- FDA (other)
- Vascular Sciences (company)
- Green Light Guru (company)
- 510(k) (other)
- PMA (other)
- De Novo (other)
- EUA (other)

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- [035 - “Safety is Safety” with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano) (Let's Combinate)
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- [147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys) (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/2021-06-07-examining-the-hhs-proposal-for-premarket-notification-exemptions. 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.