29-July-2011
A report by the Institute of Medicine, an independent advisory group the FDA enlisted for advice, has found that a common pathway for medical device approvals is flawed and that the Food and Drug Administration should develop a new process, the Star Tribune of Minneapolis reported in its article, "New Report Urges Overhaul of Medical Device Approvals."
The 510(k) process enables companies to gain product approvals for lower-risk devices by proving they are similar to ones that already have approval. But the institute's report said that's not necessarily enough to prove a device is safe and effective, the story reported.
"I fear it hasn't helped anything," said Ralph Hall, advisor in the health and life sciences group at B&D; Consulting, University of Minnesota law professor and med-tech executive. "It just added confusion and uncertainty when I think a lot of people were hoping it would have concrete, specific proposals."
Others in the industry agree with Hall that the report's lack of a specific solution makes it tougher for young device companies to raise money. Dan Sullivan, a board member at Maple Grove-based NeuroVasx, says vague approval processes make investors less likely to invest in start-ups because regulatory paths are uncertain. Sullivan told the Star Tribune that his company closed two weeks ago after dealing with five years of uncertainty and changes in the 510(k) process.
U.S. Rep. Erik Paulsen (R-MN), co-chairman of the House Medical Technology Caucus, called the report a "waste of time and money" and said he will work with his colleagues on drafting legislation to streamline and modernize approval processes for medical devices, according to the Star Tribune story.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the agency believes the 510(k) process should not be eliminated but that the agency is "open to additional proposals and approaches for continued improvement of our device review programs."
The report was praised by consumer groups such as Public Citizen's Health Research Group that have criticized the FDA in recent years amid major recalls of medical devices, according to the Star Tribune.