Prospects for FDA use of third-party certification.
At the AAMI/Food and Drug Administration (FDA) International Standards Conference in March, Ronald Chesemore, associate commissioner for regulatory affairs at the FDA, explained the agency's rationale for several pilot programs announced the following week. The programs involve preannounced inspections, annotations of items on form FDA-483-List of Inspectional Observations (FDA 483), and postinspectional correspondence. The Associate Commissioner also discussed the advantages of implementation of a third-party inspection pilot program at a future date.
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D000068:Accreditation; D002568:Certification / Q000331:legislation & jurisprudence; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*