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# ASCA Pilot Met, Exceeded Expectations: CDRH
- URL: https://www.fdaweb.com/asca-pilot-met-exceeded-expectations-cdrh/
- Published: 2024-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:26:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156655

The Accreditation Scheme for Conformity Assessment (ASCA) consolidated pilot final report issued by CDRH says the pilot, which began in 2020, “met and in some cases exceeded program expectations.” The [report](https://www.fda.gov/media/177269/download?ref=fdaweb.com) says that while the pilot called for the inclusion of five consensus standards, the program now includes 80 recognized consensus standards. Those standards are widely used, it says, and reflect areas in which accurate conformity assessment is critically important.

“While the number of ASCA summary test reports has not yet reached the levels FDA expects to review,” the report says, “only a minority of those that have been submitted contain deficiencies. FDA will continue to offer educational events and resources to address deficiencies, to reduce the number of complete test reports that inappropriately accompany ASCA submissions, and to increase the number of ASCA submissions whose cover letters make a reference to ASCA testing.”

The document also contains the ASCA 2023 annual report, which notes that as of 12/2023, FDA has granted ASCA recognition to five accreditation bodies and ASCA accreditation to 104 testing laboratories. The report lists next steps for the program including programmatic improvements, ASCA expansion, external outreach, staff training, and plans to publish an ASCA annual report on 2024 progress.