Hardware Podcasts

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

Global Medical Device Podcast · 19 Dec 2019 · 33m · Episode 129

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru
Also
FDA, ISO 17025, 510 K, PMA, Theranos

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