Hardware Podcasts

Understanding FDA's New Intended Use Rule and its Implications

Global Medical Device Podcast · 11 Aug 2021 · 35m · Episode 223

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to dissect the FDA's new 'intended use' rule, explaining how labeling content—categorized as high-level (intended use, indications for use) and low-level (directions for use)—determines regulatory burden. Drues details the concept of 'manufacturer's objective intent,' which holds companies responsible for inferred or implied uses if they have knowledge of such applications, closing loopholes previously exploited by device naming strategies. The discussion highlights the strategic trade-offs between minimizing regulatory evidence requirements and managing product liability and reimbursement risks, using stents as a key example of off-label use implications.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences
Products
Jolt Cola, Lazy Cakes, stents
Also
FDA, CDRH, CMS

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