Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) urge the Food & Drug Administration to go easy on proposed changes to the 510(k) program.
A pair of Minnesota legislators are lobbying against changes the Food & Drug Administration proposes for its 510(k) clearance protocol the industry says will hurt innovation and the state’s economy.
U.S. Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, warning that overzealous regulation would hurt start-ups struggling to raise venture capital in a weak economy.
“Bringing a new medical device to market typically involves millions, sometimes hundreds of millions, of dollars in upfront research and development costs,” wrote Klobuchar, chair of the Senate Commerce Subcommittee on Competitiveness, Innovation and Export Promotion, and Paulsen, chair of the Medical Technology Caucus. “The suggested changes could threaten the availability of often relied on equity investments.”
Calls to both Klobuchar's and Paulsen's offices seeking an explanation of the specific changes to the 510(k) program that concern the legislators were not immediately returned.
The letter comes about a week after Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, met with local industry officials in a town hall forum in Bloomington, Minn.
Here’s the full text of the letter:
May 25, 2010
Dr. Margaret Hamburg
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Dr. Hamburg,
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