FDA New Pilot Program for Medical Device Conformity Assessment Accreditation

By September 2020, the US Food and Drug Administration (FDA) is planning to launch its pilot program for medical devices conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).

ASCA Pilot Program goal is to reduce inconsistencies in testing practices, declarations of conformity and regulatory issues related to conformity assessments and medical device premarket reviews.

The ASCA pilot will specify participation and performance requirements for accreditation bodies and testing labs involved in medical device conformity assessments, as well as conditions whereby such organizations would be suspended or withdrawn from the ASCA program.

FDA is still working on the selection of standards to include in the program, but it is expected to include at least five FDA-recognized consensus standards.

FDA has focused on areas including biological evaluation of medical devices as well as basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment.

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