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# Pilot on Device Conformity Assessment Program
- URL: https://www.fdaweb.com/pilot-on-device-conformity-assessment-program/
- Published: 2019-09-20T12:00:00.000Z
- Updated: 2026-09-15T01:51:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145054

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program?ref=fdaweb.com) entitled *Pilot Accreditation Scheme for Conformity Assessment Program* that outlines goals, scope, procedures, and a suitable framework for the voluntary pilot, which was mandated by the FDA Reauthorization Act of 2017\. The program is intended to support the agency’s continued efforts to use its scientific resources effectively and efficiently to protect and promote public health. FDA says the pilot may further encourage international harmonization of medical device regulation because it incorporates elements from established international conformity assessment practices and standards (e.g., ISO/IEC 17000 series).

Under the pilot, testing laboratories may be accredited by FDA to assess the conformance of a device within certain FDA-recognized standards. It is designed to “increase consistency and predictability in the FDA's approach to assessing conformance with \[eligible\] standards in medical device premarket reviews,” a [notice](https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca?ref=fdaweb.com) says. It is also intended to “reduce regulatory burden by enhancing product reviewers’ confidence in medical device testing, which should decrease the need for internal FDA consultations, complete test report reviews, and additional information requests for standards which are part of the pilot program,” it says.