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Tentative deal reached on $595 million in medical device user fees
Medical device makers have reached a tentative deal with the Food and Drug Administration allowing the agency to collect $595 million in user fees over the next five years, both parties announced Wednesday.
The fees, which need to be approved by Congress, provide a dedicated revenue stream to pay for the federal regulators who review and approve new medical devices.
The current five-year agreement expires Sept. 30, and industry and regulators had been at odds over the length and complexity of the approval process, particularly for low-risk devices.
• reducing total review times;
• meeting with companies if they miss a performance goal on an application and working out a plan to complete work on the submission;
• providing a "substantive interaction" with applicants halfway through the targeted time for completion of review to ensure they have time to properly respond to appropriate questions; and
• hiring an independent consulting organization to analyze FDA's management of the review process.
"The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics," Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said in a statement. "The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process."
The FDA said it would develop a package of proposed recommendations for lawmakers to consider once final details of the agreement with industry are ironed out. The public will have a chance to comment on the recommendations before they are sent to Congress.
