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.

FDA logo

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."

Get the complete picture with a MassDevice Plus membership. Registered users can login here.