In re 510(k) Advisory Committee
- Case Date: 6/28/2011
- Project Name: Health Care Project
On February 27, 2012, FDA denied a Citizen Petition filed by WLF in June 2011 regarding compliance with the Federal Advisory Committee Act (FACA). The Petitioned argued that FACA bars FDA from using any advice or recommendations provided by the Institute of Medicine (IOM) committee assembled for the purpose of considering an overhaul of the 510(k) medical device approval process. WLF argued that FDA’s use of recommendations from the IOM Committee would violate FACA § 15, which provides that an agency may not use any advice or recommendations developed by an IOM committee unless the committee’s composition complies with § 15(b)(1)’s requirement that membership be “fairly balanced.” WLF charged that the IOM Committee was not fairly balanced. Numerous persons and groups directly affected by the committee’s work were unrepresented on the committee. FDA responded that it was required to defer to IOM’s assertion that the committee adequately represented all points of view.
More Information and Downloads:
6/28/2011: Download the Petition