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Industry, FDA Reach Agreement on Medical Device Fees

The Food and Drug Administration has reached an agreement on new user fees with various medical device industry groups, moving one step closer to Congressional reauthorization of fees that the FDA relies upon to ensure timely product reviews.

The FDA’s agreement in principle with groups including the Advanced Medical Technology Association and the Medical Device Manufacturers Association gives the agency a proposal it can present to Congress as part of an effort to reauthorize the Medical Device User Fee and Modernization Act of 2002.

These fees, which account for millions of dollars in funds for the agency, are due to expire at the end of fiscal 2007. MDUFMA must be reauthorized every five years.

These fees are “extremely important” for both industry and the federal government, because they provide funds the government needs to ensure timely and complete reviews of medical device applications, said Andrew Whitman, vice president of the Medical Imaging and Technology Alliance.

While industry officials are bound by a written agreement not to reveal details of the agreement, that information will be available within the next few weeks, the source added.

Although the agreement represents a step forward, both sides have a long way to go, one medical device lobbyist said.

“First and foremost, it is imperative that each of the major industry groups start the process together and stay together through the legislative dance,” said Jeffrey Kimbell, a lobbyist on medical device issues. “One undisciplined move from this point forward can easily destroy the entire agreement.”

The FDA could not be reached for comment.

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