Hardware Podcasts

Avoiding Potential Issues with your 510(k) Submission

Global Medical Device Podcast · 27 Apr 2023 · 45m · Episode 316

What this episode covers

Mike Drues, president of Vascular Sciences and former FDA consultant, discusses the 'fatal flaw' of the 510(k) regulatory pathway, specifically the risks of using predicates with known safety issues. He cites JAMA studies showing that devices based on predicates with Class 1 recalls are 6.4 times more likely to undergo similar recalls, highlighting the danger of 'predicate creep.' Drues argues against simple bans on recalled predicates, advocating instead for rigorous due diligence, tracing the genealogy of predicates, and monitoring competitor post-market surveillance to ensure patient safety and mitigate liability.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
JAMA, FDA, Institute of Medicine

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