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# FDA Fact Sheet on Device Consensus Standards Pilot
- URL: https://www.fdaweb.com/fda-fact-sheet-on-device-consensus-standards-pilot/
- Published: 2019-10-28T12:00:00.000Z
- Updated: 2026-09-15T01:59:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145353

FDA has released a [fact sheet](https://www.fda.gov/media/132042/download?ref=fdaweb.com) to explain its “Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.” The sheet provides an abbreviated overview of the guidance and pilot program. The pilot is intended to take advantage of the growing acceptance of consensus standards in medical device reviews. It is also aiming to “enhance confidence in manufacturers’ Declarations of Conformity through the use of ASCA-accredited testing laboratories,” the agency says. “In short, the FDA, relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, proposes to recognize accreditation bodies who would accredit testing laboratories to test medical devices using ASCA-eligible standards.”

FDA says that the next step would be ASCA accreditation for testing laboratories by FDA, which would allow manufacturers to engage the labs for testing to ASCA-eligible standards. “Since the test results would come from an ASCA-accredited testing laboratory, the FDA would not need to review the complete test reports supporting the Declaration of Conformity nor ask for additional information or internal FDA consultations regarding test methods unless warranted,” FDA says.