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FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report

This article was originally published in The Gray Sheet

Executive Summary

FDA released its highly anticipated proposals for reforming the 510(k) program last week, and industry reps acknowledged that many of the individual recommendations could benefit companies

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User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Device industry reps say industry-paid FDA user fees should be reauthorized for only two years, not five, to allow ongoing changes to FDA's pre-market review programs to sink in before a more meaningful user fee package is passed.

User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Device industry reps say industry-paid FDA user fees should be reauthorized for only two years, not five, to allow ongoing changes to FDA's pre-market review programs to sink in before a more meaningful user fee package is passed.

FDA 510(k) Reform Plan Yields Mixed Readings

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety of FDA's 510(k) reform plan announced January 19. Many device executives and analysts saw the agency's final decisions as a net positive for industry compared to last year's set of proposed 510(k) reforms. The tweaks, they said, respond to the aggressive lobbying by manufacturers and some members of Congress, and delay the more controversial changes for at least a number of months by pushing them over for consideration by the Institute of Medicine. Others say that the agency's game plan, while lacking in detail, should in no way be interpreted as soft on industry.

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