House reps to FDA: Regulatory changes for devices must be more transparent

October 13, 2010 by MassDevice staff

A bipartisan group of U.S. House representatives send a letter to the Food & Drug Administration asking for more transparency and greater detail from the watchdog agency as it implements changes to the 510(k) medical device clearance process.

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Twelve members of Congress sent a letter to Food & Drug Administration head Dr. Margaret Hamburg asking for more transparency from the watchdog agency as it makes changes to its 510(k) medical device clearance program.

Six Democrats and six Republicans from the U.S. House Energy and Commerce and Health, Education, Labor and Pensions committees signed the letter, writing that at least five of the FDA's proposed changes are "controversial."

The legislators are not opposed to the watchdog agency's recommendations, which went public Aug. 3, but wrote that transparency and further elaboration are needed.

The Congress members specified that recommendations covering rescission authority, split and multiple predicates, clarifying intended use and indications for use, mandatory pre-market inspections, mandatory clinical information for a subset of Class II devices and the potential release of proprietary information could disrupt the process used to clear the vast majority of medical devices.

The letter, sent Oct. 12 and obtained by the Politico website, was signed by Reps. Baron Hill (D-Ind.), Jim Matheson (D-Utah), John Barrow (D-La.), Christopher Murphy (D-Conn.), Zach Space (D-
Ohio), Jerry McNerney (D-Calif.), Joe Barton (R-Texas), Fred Upton (R-Mich.), John Shimkus (R-Ill.), Joseph Pitts (R-Pa.), Mike Rogers (R-Mich.) and Michael Burgess (R-Texas).

The way the FDA implements the recommendations could prevent companies from "using important evidence in product applications, delay the introduction of innovative new therapies increase the cost and time associated with new product development, and potentially upset the delicate balance that exists between providing information to the public and protecting intellectual property," they wrote.

The lawmakers encouraged the FDA to provide a more detailed schedule for implementing the recommendations and the agency's views on how each of the five areas could be could be best administrated.

The last request for the FDA from the congressional committees was an economic analysis of the effects of the agency's recommendations on the U.S. medical device industry.