The U.S. Food and Drug Administration (FDA) has released its annual report on its voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot, a program intended to more effectively leverage widely accepted industry standards to review and approve medical device submissions more efficiently.
The report, titled “Accreditation Scheme for Conformity Assessment (ASCA): Annual Report Calendar Year 2022,” summarizes the progress made under the program during the prior year, including device submissions and administrative efforts to support the program.
While the number of submissions received by the FDA that contain test data from an ASCA-accredited testing laboratory was limited (only 5!), the report notes that reviewers had greater confidence in submitted text results because they more closely aligned with the FDA’s own internal review checklists. That alignment also supported a more efficient review process on the part of FDA reviewers.
Specifically, in one submission, a device sponsor submitted ASCA testing data for one test and non-ASCA testing data for another. The non-ASCA test report contained five deficiencies (including one major deficiency), while the ASCA test report contained zero deficiencies and was one-fifth the length of the non-ASCA test report.
Administered by the FDA’s Center for Devices and Radiological Health, the ASCA pilot accreditation program allows device manufacturers to use one of the more than 90 currently accredited independent testing laboratories to assess medical devices for compliance with certain FDA-recognized standards. The establishment of the ASCA was mandated under the 2017 FDA Reauthorization Act.
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