DESIGN CONTROL INSPECTION SCOPE TO BE CLARIFIED BY FDA IN UPCOMING POLICY STATEMENT; FIRMS WILL CHOOSE WHICH PRODUCTS UNDERGO DESIGN CONTROL AUDITS
This article was originally published in The Gray Sheet
FDA design control inspections in the first, "transition" year of design control requirements will address design modifications to currently marketed products, new designs reaching transfer to manufacturing, and products for which a premarket approval application, 510(k) or investigational device exemption request have been submitted to FDA, Greg O'Connell, a biomedical engineer in the Center for Devices and Radiological Health's Office of Compliance, said at the Association for the Advancement of Medical Instrumentation annual meeting June 10 in Washington, D.C.
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