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FDA, Device Industry Strike Deal on Review Process Fees
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US device manufacturers have agreed to more than double the fees they pay to the FDA in order to improve the average total review time for device applications.
The deal stipulates that the industry will pay approximately $595 million over the next 5 years, plus adjustments for inflation, more than doubling the $287 million in the Medical Device User Fee Act of 2007, which is set to expire on Sept. 30.
In the deal, the FDA has agreed to performance goals, including reviewing a certain percentage of applications within a particular time frame. The agreement is expected to result in greater accountability, predictability and transparency through improvements such as a more structured pre-submission process and earlier interactions between FDA and applicants, according to a release issued by the agency. The additional funding will also allow the FDA to hire more than 200 full-time equivalent workers by the end of the 5-year program.
The deal comes as a result of more than a year of negotiations between the FDA and industry.