The FDA issued new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. The pilot program is intended to reduce the regulatory burden by enhancing the agency’s confidence in device testing.
In an October 2019 draft guidance, the agency explained that the pilot program would accredit testing laboratories to assess the conformance of a device within certain FDA-recognized standards.
The voluntary Accreditation Scheme for Conformity Assessment (ASCA) will be designed to increase consistency in the FDA's approach to assessing conformance in device premarket reviews. A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity with supplemental documentation as part of a premarket submission to the FDA.