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Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 
• By Brian Bossetta

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

Conformity Assessment
• Source: Shutterstock

When the Food and Drug Administration launched its Accreditation Scheme for Conformity Assessment (ASCA) pilot program in September 2020 its central purpose was boosting confidence in the testing results of medical devices.

To that end, the pilot allowed manufacturers to outsource some devices to ASCA-accredited labs to certify they met international standards to streamline

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