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Here's another article from the Star Tribune regarding concerns over the FDA's probable changes to its medical devices review process...

http://www.startribune.com/business/84521802.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aUUsZ

Med-tech group to discuss FDA's 510k process

Med-tech execs say changes are ill-advised

Last update: February 17, 2010 - 10:00 AM

A group of top guns from Minnesota's medical device industry will gather Wednesday to discuss the prospect that the U.S. Food and Drug Administration (FDA) is about to tighten its scrutiny of new medical products.

The newly formed Minnesota Medical Device Alliance will host a panel discussion about the FDA's 510k program, which regulates medical devices. The 510k process, which accounts for the majority of medical device approvals, is under review by the influential Institute of Medicine, a policy research branch of the National Academy of Sciences.

In addition, recently named FDA Commissioner Margaret Hamburg has called for changes in the operation of the 510k program.

Critics contend that the program doesn't require enough clinical studies of devices before they are approved for use in humans.

Minnesota's medical device community is concerned that a tougher 510k process could hamper new research and the introduction of innovative medical devices.

A steering committee for today's event includes CEOs from several local start-up companies, device entrepreneurs, legal experts and venture capitalists.

The event is at HGA Architects & Engineers in Minneapolis, with a reception at 4 p.m. and a panel discussion at 4:30 p.m.

JANET MOORE