Article preview from "The Gray Sheet"- June 25, 2012
The final bill includes device user fee reauthorization and additional FDA reforms, including a streamlined device reclassification process that has some in the device industry nervous.
Article preview from "The Gray Sheet"- June 25, 2012
Final FDA user fee and reform legislation
has cleared the House and is set for a Senate vote this week. The legislation incorporates a mix of device provisions drawn from separately passed House and Senate FDA bills, including somewhat controversial language streamlining the device reclassification process.
The compromise bill was the result of weeks of informal meetings between Senate and House staffers to come to agreement on differences between packages approved in the two chambers last month.
The legislation remains on track to reach the president for his signature before Congress’ July 4 recess, well before current FDA user fee programs expire in September.
The bill incorporates the user fee reauthorization agreement previously negotiated between FDA and the medical device industry, including $595 million (plus inflation) in industry user fees to be paid to the agency between 2013 and 2017, about double the total of the past five years.
FDA and industry have agreed to pre-market review performance goals intended to increase early interaction between reviewers and device application sponsors. They’ve also agreed to shared-outcome goals based on the total time to decision for a device, including FDA’s submission review time and industry’s time spent responding to questions.
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