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Industry Supports US FDA Conformity Assessment Concept, But Questions Abound

 
• By Elizabeth Orr

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.

US FDA’s plan to allow third-party certified device testing labs, instead of the agency, to sign off on a device firm's conformance to consensus standards should work if it’s properly implemented, manufacturers say, but some stakeholders worry that currently recognized consensus standards may not be sufficient to support an FDA pilot.

FDA committed to establishing an Accreditation Scheme for Conformity Assessment (ASCA) in the agency's MDUFA IV user-fee commitment letter. MDUFA...

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