FDA ASCA Program-Accreditation Scheme for Conformity Assessment

Accreditation Scheme for Conformity Assessment," or "ASCA," is a new program that the U.S. Food & Drug Administration (FDA) introduced in September 2020. This voluntary program was created to reduce the need for the FDA to ask manufacturers for further information during premarket submissions by increasing trust in medical device testing. The FDA converted the program from a pilot to a permanent one in September 2023.

Device manufacturers can contact ASCA-accredited laboratories to start testing after their approval. After testing, the manufacturer will receive results from the laboratory and be able to submit their premarket application to the FDA.

ASCA covers two areas: biocompatibility and basic safety and essential performance. It also includes FDA-recognized consensus standards and associated test methods. These standards categories were chosen by the FDA because they are commonly associated with regulatory requests for more information and are utilized by most devices.

The FDA received five submissions with ASCA testing, four of which included basic safety and essential performance testing and one with biocompatibility testing, according to the ASCA 2022 Annual Report. From these submissions, the following conclusions were reached:

1. All essential information and testing circumstances were contained in the declarations of conformance and ASCA Summary Test Reports, which followed the format specified in the ASCA standards-specific guidance manuals.

2. FDA reviewers were able to complete the conformity assessment portions of the device assessments quickly because they felt more confident in the ASCA testing results and because the ASCA Summary Test Reports were comprehensive and followed a similar format to the internal FDA review checklists.

3. In one submission, the device sponsor used ASCA testing for one trial and non-ASCA testing for another similar trial. The results indicated that there were no issues detected during the ASCA test review, and the report's length was only a tenth of what a usual complete test report would be. The report with non-ASCA testing had four flaws, one of which was serious, and it was around five times longer than the one with ASCA testing.

To save time during the premarket review, a lead reviewer may find it unnecessary to request consultations on a submission if a testing laboratory accredited by ASCA produces test findings using the ASCA template, therefore reducing the size of the submitted report. If you want to learn more about the statistics of ADCA, FDA had shared information during the Regulatory Education for Industry (REdI) Annual Conference 2023, which was held on June 5-9, 2023.

As the industry always seeks methods to accelerate time to market and establish more predictable regulatory deadlines for submission, ASCA might offer that benefit—at least in terms of biocompatibility, basic safety, and essential performance.