# Submitting a 510(k) using FDA's Safety and Performance Based Pathway

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-09-02
- Length: 45m
- Episode: 162
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway
- Listen: https://podcast.greenlight.guru/episode/submitting-a-510k-using-fdas-safety-and-performance-based-pathway

## Summary

Mike Drues from Vascular Sciences explains the FDA's Safety and Performance Based 510(k) (SP 510(k)) pathway, noting it applies only to Class 2 or lower devices with well-established technologies like cutaneous electrodes and Foley catheters. He argues the pathway is politically motivated to compete with EU regulations and is currently too limited, suggesting industry should proactively define standards rather than waiting for FDA guidance. Drues proposes applying Product Development Protocol (PDP) logic to expand the program, urging companies to engage in pre-submission meetings to ensure testing completeness.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=0) Introduction: SP 510(k) Overview and Requirements
- [3:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=221) Comparison: Traditional, Special, and SP 510(k) Pathways
- [7:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=424) SP 510(k) Eligibility: Well-Established Technologies and Standards
- [11:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=695) Political Motivations and Current Status of SP 510(k)
- [14:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=875) Finalized and Draft Guidance: Electrodes, Catheters, and Implants
- [21:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=1297) Proposed Improvements: Industry-Led Standards and PDP Logic
- [30:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=1809) Pre-Submission Strategy and Avoiding Rejection
- [38:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway#t=2283) Final Recommendations: Know Your Options and Communicate Early

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- Foley catheter (product)
- cutaneous electrodes (product)
- Greenlight Guru (company)

## Related episodes from other shows

- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [024 - "Operating Under Constraints "with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)

## 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/2020-09-02-submitting-a-510-k-using-fdas-safety-and-performance-based-pathway. 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.