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...