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Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot

 
• By David Filmore

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

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US FDA says its upcoming accreditation scheme pilot to streamline the agency's review of companies' conformance to standards is an important part of the effort to modernize and globally harmonize pre-market reviews. But questions about what manufacturers will tangibly gain from the program, what the costs will be and the challenges of incorporating specific standards still need to be answered.

The agency convened a workshop May 22-23 at its Maryland headquarters to discuss the Accreditation Scheme for Conformity Assessment (ASCA) for medical devices. The ambitious program was hatched in the most recent MDUFA IV user-fee negotiations, and FDA has committed to getting it off the ground by fiscal year 2020

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