House Lawmakers Ask FDA to Delay Implementation of Certain 510(k) Changes

By Carmelina G. Allis –

We previously reported on FDA’s August 2010 publication of a report recommending changes to the 510(k) program.  We 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.  Lawmakers from the U.S. House of Representatives also have concerns with some of the recommended changes.

On October 12, 2010, House lawmakers sent a letter 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 particular, the lawmakers have 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.  Those recommendations are “considered controversial” by lawmakers, raising concerns that their implementation could “prevent companies from using important evidence in product applications,” “delay the introduction of innovative new therapies,” and “potentially upset the delicate balance that exists between providing information to the public and protecting intellectual property.”

Although the Representatives do not oppose the recommendations, they request “more transparency from FDA” on those issues.  The letter asks the agency to provide more details about those recommended changes before they are implemented, such as a detailed work schedule for implementing the recommendations, which changes will be implemented pursuant to guidance documents, rulemaking, or statutory amendments, and an analysis of the economic impact of the recommendations on the domestic medical device industry.

The lawmakers also request that the agency “ensure that proper and appropriate public comment is solicited before moving forward.”  Emphasizing the need for more transparency, the Representatives commended the agency on its efforts for keeping “the public[] and the medical technology community informed and engaged” in this process.