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IMPLEMENTATION OF FDA MODERNIZATION ACT'S COLLABORATIVE PMA REVIEW PROVISIONS FOCUS OF NOV. 24 AGENCY/INDUSTRY MEETING; CDRH DEVELOPING COST ESTIMATE

This article was originally published in The Gray Sheet

Executive Summary

Implementation of the collaborative premarket review provisions in the FDA Modernization Act was a major topic of discussion at a Nov. 24 meeting at FDA's Rockville, Maryland headquarters attended by device industry reps, Center for Devices and Radiological Health Director Bruce Burlington and other senior device center officials.
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