April 1, 2021
At the end of 2019, the U.S. Food and Drug Administration (FDA) announced the new voluntary pilot program, ASCA. The program is intended to enhance confidence in medical device testing when performed by an ASCA-accredited laboratory and ensure patients have timely and continued access to safe, effective, and high-quality medical devices The purpose is to decrease the need for additional information requests concerning testing from the FDA during premarket submissions by utilizing FDA-recognized consensus standard(s) eligible for inclusion in the ASCA pilot.
According to FDA.gov, “The pilot is intended to increase consistency and predictability in the FDA's approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews.”
Created with input from experts across the medical device manufacturing and standards conformity assessment communities, the program:
- Decreases the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories
- Incorporates existing international conformity assessment standards and practices where practical
When discussing the program, UL Principal Engineer Pamela Gywnn refers to the FDA website which states, “The voluntary ASCA Pilot is intended to enhance product reviewers' and device manufacturers' confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA Pilot.”-
To help you further understand the implications of ASCA, UL conducted a webinar on Feb. 16, 2021. Principal Engineer Pamela Gwynn and Operations Manager Jack Steiner presented information concerning the FDA’s ASCA pilot program.
Key topics included:
- Overview of the voluntary ASCA program and why it was developed
- Standards included in the pilot program: a subset of FDA-recognized consensus standards
- High-level review of the process
- Manufacturer and test laboratory responsibilities
- Important dates: The FDA will announce their initial list of accepted laboratories on or before April 12, 2021.
After the discussion, Gwynn and Steiner answered numerous questions from participants during the Q&A session.