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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-08-03
- Length: 40m
- Episode: 330
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits
- Listen: https://podcast.greenlight.guru/episode/330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=0) Introduction to 3P510k and BeanStock Ventures
- [3:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=230) How the 3rd Party Review Program Works
- [7:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=424) Why the Program is Underutilized
- [9:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=543) Eligible Product Codes and Risk Levels
- [12:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=753) Qualification and Accreditation Requirements
- [16:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=1011) FDA Grading System and Reviewer Performance
- [25:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=1552) Vetting Reviewers and Common Pitfalls
- [32:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits#t=1953) Cost Comparison and Startup vs. Enterprise Benefits

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies, large enterprises

## Mentioned

- BeanStock Ventures (company)
- FDA (other)
- Greenlight Guru (company)

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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-03-330-3p510k-what-is-a-510k-3rd-party-review-and-what-are-the-benefits. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.