What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

December 18, 2019

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FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme for Conformity Assessment (ASCA). This Pilot Program allows accredited testing laboratories to evaluate medical device registrants’ conformity to eligible consensus standards.

Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the nuances of this pilot program, as well as provide insights and opportunities that can help device makers.




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Some highlights of this episode include:

  • Medical device companies have three options: Select accredited/certified testing lab, select non-accredited/non-certified testing lab, or conduct their own testing.
  • There are definite advantages to selecting accredited/certified testing labs through the ASCA Pilot Program. 
  • How does the ASCA Pilot Program compare to Digital Health Software Pre-certification? Minor changes can be implemented without FDA approval. 
  • The device manufacturer is ultimately responsible for inclusion of appropriate device testing information and standards are selected and used properly.
  • The ASCA Pilot Program is voluntary, but should it be mandatory to avoid major complications and conflict of interest? 
  • FDA pilot programs often languish and guidances remain in draft form. The government is known for taking its time, but it makes sense to perform tests. 
  • Why is ASCA Pilot Program important? What’s in it for medical device professionals? Depends on device competition and selected testing option.



FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

ISO 17025

De Novo

Pre-market Notification 510(k)

Pre-Market Approval (PMA)

FDA Digital Health Software Pre-certification Program

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru


Memorable Quotes by Mike Drues:

“FDA will likely look into the details more stringently to make sure that the people that did the testing, did it correctly.” 

“This is not a shifting of responsibility.” 

“The device manufacturer is ultimately responsible for the inclusion of the appropriate device testing information.”



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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