CDRH ASCA Pilot on Schedule, Expecting Submissions

CDRH says its Accreditation Scheme for Conformity Assessment (ASCA) pilot program is on schedule, with 53 test labs having been granted ASCA accreditation. ASCA team member Angela DeMarco told a 5/20 Webinar “the ASCA pilot is in full swing now that test labs have been accredited and review staff have been trained and we’re hoping to see device submissions soon.”

The Webinar updated participants on the pilot and provided information on how to apply for ASCA accreditation and how to effectively participate in the pilot.

DeMarco said the pilot was designed to increase FDA confidence in test methods and results contained in medical device submissions. She said that with enhanced agency confidence, manufacturers should see fewer requests for additional information on testing methods from an ASCA accredited test lab. And that should lead to a review process that is more consistent, predictable, and efficient.