Minnesota Lawmakers Send Letter to FDA with Concerns About the 510(k) Process

By Jeffrey K. Shapiro & Carmelina G. Allis –

FDA’s review of 510(k) program continues to cause concern in Congress. 

On November 24, 2010, the Minnesota delegation, including unlikely collaborators Senator Al Franken and Representative Michele Bachmann, sent a letter to Dr. Hamburg asking “FDA to review the impact of its recommendations [to the 510(k) program] on patient access as well as [Minnesota’s] economy.” 

They stated:  “As members of the Minnesota delegation, we want to work with the FDA toward a larger goal of saving and improving patients’ lives. . . Changes that may jeopardize that goal should not be made unless there is clear evidence that the changes are necessary to address a demonstrated public health problem.” 

The Minnesota lawmakers made clear that FDA should ensure that changes to the 510(k) program not stifle innovation or delay patient access to new treatments.

We previously reported on FDA’s August 2010 report recommending changes to the 510(k) program.  Our earlier post briefly discussed the proposed changes, and raised concerns with some of the agency’s recommendations because of their potential negative effect on the medical device industry and the 510(k) program. 

We also previously reported on an October 12, 2010, letter sent by House lawmakers to FDA’s Commissioner Dr. Hamburg asking to delay the implementation of certain changes that the agency is considering for the 510(k) program.  In the letter, the lawmakers raised concerns with the agency’s recommendations regarding rescission authority, split and multiple predicates, intended use and indications for use, mandatory pre-market inspections and clinical data for a subset of Class II devices, and proprietary information.