by Brendon Nafziger
, DOTmed News Associate Editor | August 03, 2011
Both Minnesota's senators and one congressman defended the Food and Drug Administration's 510(k) clearance process from the Institute of Medicine's calls to scrap it
, with one senator slamming the IOM's recommendations as "very harmful."
Sens. Amy Klobuchar (D) and Al Franken (D) and Rep. Erik Paulsen
(R) issued a joint statement saying they wanted to preserve the so-called fast track clearance process. They also said they supported "targeted reforms" that would cut red tape and speed up getting new devices to market.
"Calling for the elimination of the 510(k) process could be very harmful to innovation," Franken said in a statement. "The report's recommendations would impose new burdens on the medical device industry, without a clear path to a more effective process."
The politicians are reacting to IOM's long-awaited report, dropped last Friday, which called for eliminating the 510(k) process and re-making it from the ground up. The group found the process was not able to verify the safety or effectiveness of devices, and did not require new products to be innovative.
The 35-year-old 510 (k) process is used to bring to market moderate-risk, Class 2 devices, including most radiological equipment. The FDA received about 4,000 510(k) submissions in 2009, the IOM said.
But Minnesota politicians know their audience. The Midwest state is a medical device hub, home to some of the industry's biggest companies, including Medtronic, Boston Scientific, 3M and St. Jude Medical. About 35,000 Minnesotans are employed by device companies in the state.