ASCA Annual Report Issued

CDRH says it has published three final guidance documents implementing the voluntary Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The Center’s 2020 ASCA annual report identifies the three documents as a program guidance, basic safety and essential performance standards-specific guidance, and biocompatibility standards-specific guidance.

“The ASCA pilot is anticipated to augment confidence in and reliance upon declaration of conformity to the FDA-recognized standards included in the ASCA pilot,” the report says. “The outcome is intended to translate into greater consistency and predictability in FDA’s approach to assessing conformance to standards in medical device review by enhancing FDA’s confidence in the testing laboratories’ test methods and results. Ultimately, we expect that the ASCA pilot will help FDA ensure safe, effective, and high-quality medical devices are available to patients without unnecessary delay.”