FDA 510(k) Reform Plan Yields Mixed Readings

Executive Summary

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.