# CDRH Proposed Guidance for FY 2023

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-12-22
- Length: 43m
- Episode: 295
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023
- Listen: https://podcast.greenlight.guru/episode/cdrh-proposed-guidance-for-fy-2023

## Summary

Mike Drues, President of Vascular Sciences, joins host John Spear to analyze the FDA CDRH’s proposed guidance priorities for Fiscal Year 2023, detailing the specific items on the A-list and B-list. Drues highlights key regulatory shifts regarding COVID-19 transition plans, cybersecurity for Software as a Medical Device (SaMD), and the controversial 'locked algorithm' requirement for AI/ML devices. The conversation emphasizes that guidance documents are non-binding interpretations of regulations, urging engineers to use professional judgment rather than following them blindly, and discusses how companies can leverage regulatory strategy for competitive advantage.

## Chapters

- [1:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=84) Introduction: Mike Drues and Vascular Sciences
- [1:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=115) Context: FDA CDRH Priority Lists (A-list vs B-list)
- [5:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=313) A-List Priorities: COVID, Cybersecurity, and Breakthrough Device Program
- [12:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=772) B-List Priorities: Biocompatibility, AI/ML, and Electrical Safety
- [19:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=1166) Missing Topics and the Role of Standards Organizations
- [23:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=1437) Should FDA Provide Guidance? Industry Responsibility
- [29:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=1787) Final vs. Draft Guidance: Evolutionary Nature of Regulation
- [33:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=2011) Compliance: Must Manufacturers Follow Guidance?
- [37:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-22-cdrh-proposed-guidance-for-fy-2023#t=2272) Competitive Regulatory Strategy and Due Diligence

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- CDRH (other)
- ISO 13485 (other)
- ISO 14971 (other)
- 510 K (other)
- De Novo (other)
- PMA (other)
- EUA (other)
- SaMD (other)
- BDP (other)
- ASCA (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/2022-12-22-cdrh-proposed-guidance-for-fy-2023. 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.