CDRH Proposed Guidance for FY 2023

Global Medical Device Podcast · 22 Dec 2022 · 43m · Episode 295

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: Greenlight Guru, Vascular Sciences
Also: FDA, CDRH, ISO 13485, ISO 14971, 510 K, De Novo, PMA, EUA, SaMD, BDP, ASCA

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CDRH Proposed Guidance for FY 2023

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

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