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.