Hardware Podcasts

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

Global Medical Device Podcast · 3 Aug 2023 · 40m · Episode 330

What this episode covers

Shawnnah Monterrey, founder of BeanStock Ventures, explains the 510(k) 3rd Party Review (3P510k) program, an FDA initiative allowing accredited reviewers to handle lower-risk device submissions to reduce backlog. She details how the program offers guaranteed timelines and predictable costs, benefiting both startups seeking investor assurance and large corporations needing predictable R&D schedules. Monterrey emphasizes that the program is underutilized due to lack of awareness and advises companies to vet reviewers based on domain expertise rather than just price, warning against using the review as a free filter for incomplete submissions.

Most relevant to

early-stage companies and large enterprises

Topics

Mentioned

Companies
BeanStock Ventures, Greenlight Guru
Also
FDA

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