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.
You may also be interested in...
Device Innovation: Report Paints Dire Picture; Prez, FDA Take "Positive" Steps
Last week started off with a particularly negative appraisal for the prospects of continued U.S. leadership in medical device innovation under current policies, but it was followed by two developments that almost appeared as corrective responses by the federal government.
FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report
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
Lack Of Industry Involvement In Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.