By Jeffrey K. Shapiro –
A group of nine U.S. Senators has sent a letter to FDA expressing concern over potential changes to the 510(k) medical device clearance program. The letter is similar to a November 2010 letter from Minnesota lawmakers and an October 2010 letter from House lawmakers (see our previous posts here and here). Each letter takes issue with FDA’s August 2010 report recommending changes to the 510(k) program, which we reported on last year.
The Senatorial letter points to several “controversial” recommendations that “have the potential to disrupt the current regulatory balance under the 510(k) pathway, jeopardizing patients' timely access to new treatments and cures.” In particular, the Senators “believe that the recommendations regarding rescission authority; split and multiple predicates; intended use and indications for use; splitting Class II; and the treatment of proprietary information, including trade secrets could have significant unintended adverse consequences on the existing regulatory process.”