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# ASCA Pilot Program Explained
- URL: https://www.fdaweb.com/asca-pilot-program-explained/
- Published: 2020-11-17T12:00:00.000Z
- Updated: 2026-09-14T16:36:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148106

A 10/22 CDRH Webinar provided background information and an overview of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. In the [presentation](https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-accreditation-scheme-conformity-assessment-asca-pilot-program-final-guidances-10222020?ref=fdaweb.com), CDRH Standards and Conformity Assessment Program senior policy analyst **Stacy Cho** said that during the MDUFA 4 reauthorization negotiations, FDA and industry agreed to establish a conformity assessment accreditation scheme for testing laboratories that evaluate medical devices according to certain FDA recognized standards.

The program was developed, she said, because evidence of conformity to one or more FDA recognized standards is often a thorough and efficient way for a manufacturer to address certain questions of safety and/or effectiveness.

“This is why FDA invests time and personnel into participating in various standards working groups so that the agency may have input in the development of these different medical standards,” she said. “For manufacturers and FDA to benefit from this efficiency, FDA must have confidence in the Declaration of Conformity submitted by device manufacturers in their pre-market submission.”

Cho said the agency is collaborating with the National Institute of Standards and Technology to develop the ASCA pilot program using best practices as established by experts in conformity assessment.