Minnesota group aims to bolster support for FDA's 510(k) program

January 13, 2010 by MedCity News

A new steering committee of medical device players in the Land of 10,000 Lakes wants to dampen criticism of the Food & Drug Administration's 510(k) clearance program.

By Thomas Lee

MINNEAPOLIS, Minnesota — For months, the medical device community has been fretting over what they see as the Food & Drug Administration's increasingly heavy-handed way of approving new technologies.

Now a newly formed grassroots group wants to fight back. The Minnesota Medical Device Alliance Steering Committee (PDF), made of some of the state's most prominent investors, attorneys, and executives, is hosting a meeting in February to discuss ways to push back against critics of the 510(k) program.

They have a lot of work to do. The 510(k) program allows the FDA to approve devices that are similar to other technologies already on the market. Yet under pressure from the Democratic-controlled Congress and Obama administration, the FDA has made it increasingly difficult to win 510(k) clearance by imposing costly and unnecessarily strict testing requirements on start-ups who can least afford them, said Mark DuVal, a local attorney and FDA specialist seeking to mobilize Minnesota's med tech industry.

The 510(k) scrutiny hasn't received the same amount of attention than, say, the proposed $20 billion medical device tax to help fund healthcare reform. But the issue matters far more to the med-tech industry because toughening or even eliminating the 510(k), as some people fear, will stifle innovation by blocking companies from delivering promising technologies to market, DuVal said.

Not sure how the new alliance will differ from industry organizations like LifeScience Alley and Advanced Medical Technology Association (AdvaMed). But judging from the group's roster, it's clear that some of Minnesota's most prominent brains feel more needs to be done:

Jim Bullock, Atritech
Mark DuVal, DuVal & Associates
Kris Johnson, Affinity Capital Management
Tom Letscher, Oppenheimer Wolff & Donnelly LLP
Rich Lunsford, Anulex Technologies
Mark McKoskey, MedTech Resource Alliance
Pete McNerney, Thomas, McNerney & Partners
Dave Stassen, Split Rock Partners
Eric Timko, NeuroVasx Inc.

"As we all know, the 510(k) program has been under siege for some time and is facing greater challenges than ever in the wake of proposed administrative and legislative changes. Because the end product will have an enormous impact on Minnesota's medical device and investment communities, we must act now and make our voices heard at FDA and Congress."