FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from "The Gray Sheet" - January 24, 2011

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety from FDA's 510(k) reform plan announced Jan. 19.

FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from "The Gray Sheet" - January 24, 2011

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety from FDA's 510(k) reform plan announced Jan. 19.

Many device reps 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. (See " FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report " – "The Gray Sheet" Aug. 9, 2010.)

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.

IOM was asked by FDA to do an independent analysis of the 510(k) program and is expected to issue its recommendations by spring or summer of this year.

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