Industry Supports US FDA Conformity Assessment Concept, But Questions Abound
Manufacturers and trade groups generally support an FDA plan to pilot a program that would outsource some standard-conformance certification to outside device testing labs. But companies have questions, and some are urging the agency to consider some standards it currently does not recognize to be included in the pilot.
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Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot
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.
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
In the latest user-fee agreement, FDA and industry agreed to pilot a conformity assessment program where third-party accredited test labs could affirm a manufacturer's conformance to consensus standards, potentially expediting pre-market reviews.