# A Regulatory Gap Analysis of FDA's Systems & Policies

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-01-26
- Length: 53m
- Episode: 244
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies
- Listen: https://podcast.greenlight.guru/episode/a-regulatory-gap-analysis-of-fdas-systems-policies

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer of Greenlight Guru to conduct a gap analysis of the FDA's regulatory framework, arguing that the system is too reactive. Drues identifies 'predicate creep' in the 510(k) process and 'change creep' via letters-to-file as major inefficiencies, proposing a 'ketchup 510(k)' to aggregate minor changes. He also advocates for a formal mechanism to designate wellness devices, a '510(k)-like PMA' for incremental Class 3 innovations, and a dedicated pathway for personalized medicine, such as 3D printed devices.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=154) The Problem with Reactive Regulation and CAPA
- [6:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=383) 510(k) Reform and Predicate Creep
- [8:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=527) The Missing Mechanism for Wellness Devices
- [14:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=865) Change Creep and the 'Ketchup 510(k)' Proposal
- [23:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=1385) Post-Market Communication and 483/WL Responses
- [28:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=1696) Creating a 510(k)-like PMA for Class 3 Devices
- [37:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=2252) Safety-Only Approval and the EUA Precedent
- [42:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=2574) Combining BDP and STeP Programs
- [46:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies#t=2762) The Need for a Personalized Medicine Pathway

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- 510(k) (other)
- CAPA (other)
- Custom Device Exemption (other)
- Breakthrough Devices Program (other)
- Safer Technologies Program (other)

## Related episodes from other shows

- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c) (Let's Combinate)
- [Closing the gap between Regulatory and Development with Milton Yarberry](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry) (The Pragmatic Embedded Podcast)

## 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/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies. 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.