US FDA Seeks Input On Standing Up Conformity Assessment Pilot
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.
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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.
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
Under a provision in the 21st Century Cures bill, which is accelerating towards enactment, FDA may need to consider recognizing more standards, which could speed up review times for 510(k)s. But it is also likely to add a burden for the agency.