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Targeted Industry Sampling Approach To Inspections Envisioned by CDRH

This article was originally published in The Silver Sheet

Executive Summary

CDRH "STRATEGIC VISION" FAVORS LIFE CYCLE MODEL to medical device regulation. The Center for Devices and Radiological Health's recently unveiled "strategic vision" outlines long-term goals for the center, including adoption of a "total product life cycle" (TPLC) approach that would replace the current premarket/postmarket regulatory paradigm. As part of its nascent vision, CDRH is looking at pursuing targeted sampling of its inspection inventory in lieu of the current firm-by-firm approach. An internal review of the center's science activities based on the TPLC model and the establishment of a pilot quality system for CDRH are among the initial projects planned under the strategic vision initiative WARNING LETTERS: Consultant certification of corrective actions requested for QS reg deficiencies at Visions in Endosurgery, Associates of Cape Cod; ChromaVision promotions require marketing approval, FDA says
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