FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from IN VIVO - February 1, 2011

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.

FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from IN VIVO - February 1, 2011

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 (IOM). 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. Others say that the agency's game plan, while lacking in detail, should in no way be interpreted as soft on industry.

The 510(k) report implements most of the agency's proposed reforms in their original or modified forms. FDA named 25 specific actions it will take this year toward implementing the recommendations, with projected timelines. Among those actions, the agency calls for establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

CDRH plans to improve reviewer training and streamline its de novo approval process for moderate-risk devices that lack a predicate. The center also plans to issue draft guidance on when clinical data should be submitted in 510(k)s, and device-specific guidances are planned to clarify additional requirements on a case-by-case basis.

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