Devicemakers Claim Some Reviewers Using 510(k) Changes Prematurely

While CDRH has yet to officially adopt any of its recommendations for changing the 510(k) clearance program, devicemakers say agency reviewers are already putting some of the proposals into practice. Staff members have been told not to use any of the suggestions made by a CDRH work group in August until the center decides which ones it will pursue, Christy Foreman, acting director of CDRH’s Office of Device Evaluation, said at the 2010 AdvaMed Medtech Conference last week.
Devices & Diagnostics Letter