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
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
The deal comes as a result of more than a year of negotiations between
the FDA and industry.