CDRH: Changes to 510(k) Process in Store for Later This Year

The 510(k) clearance process is slated for revision by Sept. 30, topping CDRH’s list of plans for 2010 as CDRH Director Jeffrey Shuren steers the center into the next decade. In one of his first interviews since permanently becoming CDRH director, Shuren said he plans to review public comments from a meeting this month and the findings of an internal review, to be completed this summer, before making any proposals.
Devices & Diagnostics Letter