FDA reaches agreement with medical device lobby for user fees

The Advanced Medical Technology Association and FDA have reached an agreement in principle regarding reauthorization of the Medical Device User Fee and Modernization Act, according to AdvaMed President Steven Ubl, CQ HealthBeat reports.

Reauthorization of the user fee act is expected later this year.

Ubl on Tuesday said the agreement would make user fee increases more consistent and reduce agency review times.

Ubl declined to provide additional details. An FDA spokesperson confirmed that the agency reached an agreement with AdvaMed.

Ubl also discussed AdvaMed's policy agenda for the year, which includes working for passage of legislation that would establish Medicare reimbursements for doctors who use "remote monitoring technologies" to track chronic conditions.

Ubl said his group supports legislation that would alter how Medicare pays for new clinical lab tests that target therapies to individual patients.

Ubl added that AdvaMed is concerned about "the breadth and depth of reductions being discussed" for Medicare reimbursements (Carey, CQ HealthBeat, 2/27).