# #343: Recent FDA Draft Guidances

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-11-09
- Length: 53m
- Episode: 343
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances
- Listen: https://podcast.greenlight.guru/episode/343-recent-fda-draft-guidances

## Summary

Regulatory expert Mike Drues joins the Global Medical Device Podcast to dissect three recent FDA draft guidances on the 510(k) pathway, focusing on predicate selection, clinical data requirements, and permanent implants. Drues argues that while the FDA is attempting to raise safety standards through non-binding guidance, the underlying 510(k) regulation has remained unchanged since 1976, creating a gap between regulatory expectations and enforceable law. He emphasizes that clinical data needs are driven by engineering and biological factors rather than regulatory pathways, and warns against using predicates with known design-related recalls.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances#t=0) Introduction and Historical Context of the 510(k)
- [7:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances#t=459) Best Practices for Selecting a Predicate Device
- [23:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances#t=1414) Clinical Data Requirements in 510(k) Submissions
- [36:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances#t=2177) Evidentiary Expectations for 510(k) Implant Devices
- [50:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances#t=3006) Future of Medtech and Regulatory Changes

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- Greenlight Guru (company)
- 510(k) (other)
- G2 (company)
- ISO (other)
- IOM (company)

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- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r) (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)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (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/2023-11-09-343-recent-fda-draft-guidances. 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.