USA – US FDA publishes trio of final guidances for Accreditation Scheme for Conformity Assessment (ASCA) program

As the US Food and Drug Administration formally launches the pilot for its Accreditation Scheme for Conformity Assessment (ASCA) program to streamline testing requirements in medical device premarket reviews, the agency has published three final guidances addressing ASCA program goals, scope and acceptable testing standards.

FDA intends for the ASCA program to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. Utilizing accredited testing labs would help make medical device and IVD premarket reviews more consistent and efficient, according to the regulator…