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# AdvaMed Ideas to ‘Help ASCA Achieve its Promise’
- URL: https://www.fdaweb.com/advamed-ideas-to-help-asca-achieve-its-promise/
- Published: 2024-05-22T12:00:00.000Z
- Updated: 2026-09-14T14:31:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157038

Commenting on an FDA virtual public workshop about expanding the Accreditation Scheme for Conformity Assessment (ASCA), AdvaMed says it believes there is significant promise in the program and has suggestions intended to help ASCA achieve its promise now that the pilot is a permanent program. In its [letter](https://downloads.regulations.gov/FDA-2024-N-0645-0009/attachment%5F1.pdf?ref=fdaweb.com), the association says it is pleased that FDA plans to revise the three ASCA guidances and issue updated drafts in FY 2024 to reflect lessons learned during the pilot and the now permanent nature of the program. It asks that FDA consider these comments that the agency should:

- only request the full test report in the rarest of circumstances;
- be mindful in the language it uses to describe laboratories participating in the program, consistent with its voluntary nature;
- include as many standards as possible in the program, including ones with an element of risk management and essential performance;
- advocate for the ASCA-accredited test laboratories to leverage supplemental documents that will support a sufficient and consistent conformity assessment for essential performance; and
- provide additional granularity when reporting metrics.