Hardware Podcasts

#343: Recent FDA Draft Guidances

Global Medical Device Podcast · 9 Nov 2023 · 53m · Episode 343

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Greenlight Guru, G2, IOM
Also
510(k), ISO

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