Prospects for FDA use of third-party certification
Chesemore, R.
Biomedical Instrumentation and Technology 30(5): 457-458
1996
ISSN/ISBN: 0899-8205 PMID: 8909708 Document Number: 456964
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.