FDA Readies Accreditation Scheme for Conformity Assessment Pilot

February 18, 2021

The FDA’s Center for Devices and Radiological Health is preparing to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program that will allow accredited testing labs to assess a device’s conformance with agency-recognized standards.

The concept of the ASCA pilot emerged from discussions with devicemakers during negotiations for the Medical Device User Fee Amendments (MDUFA IV) in 2017.

The FDA hopes that having greater confidence in laboratories’ test methods and results will mean more consistent and predictable assessments of conformance to standards.

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