Hardware Podcasts

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Global Medical Device Podcast · 27 Jul 2022 · 44m · Episode 273

What this episode covers

Mike Drues of Vascular Sciences, joined by hosts Jon Speer and Etienne Nichols, explains the FDA’s Refusal to Accept (RTA) policy, noting that approximately 60% of 510(k) submissions are rejected during administrative review due to company errors. Drues highlights that while electronic tools like eSTAR help organize submissions, they do not evaluate content quality, leading to rejections for missing sections, inconsistent labeling, or failure to use current forms. The discussion emphasizes that companies must proactively explain 'Not Applicable' sections and treat the FDA as a customer rather than a beta tester to avoid delays.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
FDA, Vascular Sciences, Green Light Guru
Products
510(k), De Novo, PMA
Tools
eSTAR

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