# What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-12-19
- Length: 33m
- Episode: 129
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur
- Listen: https://podcast.greenlight.guru/episode/what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufacturers

## Summary

Mike Drues, president of Vascular Sciences, joins host John Spear to explain the FDA's Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, which allows third-party testing labs to become accredited to perform safety and efficacy testing for medical devices. Drues outlines the three options for manufacturers—using accredited labs, non-accredited labs, or self-testing—and highlights that using an accredited lab simplifies the 510(k) or PMA submission by acting as a 'tick box' for the FDA. He argues that while the program is voluntary, it offers significant advantages for 'Me Too' devices with established standards, whereas novel devices may still require proprietary testing strategies managed directly by the manufacturer.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=0) Introduction: ASCA Pilot Program Overview
- [2:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=124) ASCA Mechanics and ISO 17025 Accreditation
- [6:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=416) Advantages of Accredited Labs for Submissions
- [10:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=602) Manufacturer Responsibility and Conflict of Interest
- [15:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=942) Comparison to Digital Health Pre-cert and Theranos
- [21:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=1262) Pilot Program Longevity and Government Expediency
- [24:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur#t=1479) Strategic Advice for Me Too vs. Novel Devices

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- Vascular Sciences (company)
- Greenlight Guru (company)
- ISO 17025 (other)
- 510 K (other)
- PMA (other)
- Theranos (other)

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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/2019-12-19-what-is-fdas-asca-pilot-program-and-how-does-it-impact-medical-device-manufactur. 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.