UL Solutions will host a webinar next month on the U.S. Food and Drug Administration voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot program for medical devices.
The ASCA program was designed to improve the premarket review process, increasing FDA product reviewers’ and device manufacturers’ confidence in medical device testing when performed by an ASCA-accredited laboratory and reducing the need for additional information during the premarket review process. FDA and UL Solutions representatives will speak on the FDA’s role in the U.S. and classification of medical devices; the approval processes for 510(k) and PMA; the ASCA program’s goals, steps, deliverables, and benefits; and how to combine ASC A with other certification processes.
“U.S. Market Access for Medical Devices: FDA and ASCA Program” will be held on Thursday, October 6, at 2pm CEST. Visit the UL Solutions website to learn more and register at no cost.