Will Republican Takeover Of House Slow 510(k) Reforms?

Article preview from "The Gray Sheet" - November 8, 2010

The shift to Republican leadership in the House following the Nov. 2 election means the device industry will find a more sympathetic ear in Congress on 510(k) reforms and reauthorization of medical device user fees, device policy insiders say.

Will Republican Takeover Of House Slow 510(k) Reforms?

Article preview from "The Gray Sheet" - November 8, 2010

The shift to Republican leadership in the House following the Nov. 2 election means the device industry will find a more sympathetic ear in Congress on 510(k) reforms and reauthorization of medical device user fees, device policy insiders say.

"The Republican majority likely will require FDA to publicly justify its proposals with respect to the upcoming MDUFA [user fee] reauthorization and the agency's 510(k) recommendations, bringing increased scrutiny to FDA's efforts to make changes to the program," said Brett Loper, a top lobbyist with AdvaMed.

John Manthei, a partner with the law firm Latham & Watkins, agrees. “I think the focus of GOP oversight will be concerns that the pendulum has in fact swung too far; that FDA’s been too aggressive on a post-market basis and has unnecessarily slowed down drug and device reviews,” he said.


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