FDA Proposes Changes to the 510(k) Program; Seeks Public Comment
This post was written by Paul Sheives and Areta Kupchyk.
FDA has made available for comment two reports from internal agency workgroups, one from the Center for Devices and Radiological Health (CDRH) 510(k) Working Group, and another from the Task Force on the Utilization of Science in Regulatory Decision Making. The recommendations proposed in the documents are preliminary. Among the proposed changes are providing information on how FDA will review 510(k)-regulated devices for the true intended use (compared to solely the labeled indication), and fragmenting the categorization of Class II devices for more appropriate data requirements for devices that present similar risk profiles. FDA is accepting written comments on the proposed changes until October 4, 2010.
