The FDA’s collection of user fees from medical device companies surged nearly 50% in fiscal 2013, according to a quarterly report on the user fee program.
The jump in user fees paid by medtech makers to have their products reviewed was due to a new Medical Device User Fee Act that went into effect after fiscal 2012 ended in October of that year. Excluding unearned fees and refunds, the user fees collected in fiscal 2013 were $96.8 million, a 48.9% jump over the $65.0 million collected during fiscal 2012, according to the report.
Another significant jump occurred between 2007, when the 1st MDUFA period closed, and the next year when MDUFA II went into effect. User fees jumped 65.5% to $47.5 million for fiscal 2008, according to the report.
The FDA had taken in in a total of $98.3 million in registration and application fees as of March 31, the halfway point of its fiscal year, issuing $328,000 in refunds for a net collection of $97.9 million. The total authorization for fiscal 2014 is $115 million, according to the report, meaning the agency’s Center for Devices & Radiological Health has pulled in 85% of its authorization in just 6 months.
The average time to a 510(k) decision when the application cohort was 99.7% closed was 144 days in fiscal 2012, when there were 1,839 applications. That number fell 23.8% to 1,402 the next year; there were 1,346 510(k) applications as of March 31 excluding applications that were not accepted for substantive review, according to the report. About 84% of 510(k) submissions won a "substantially equivalent" determination from the FDA so far in fiscal 2014, compared with 79% for fiscal 2013.
For pre-market approval submissions, the average time to decision when the cohort was 98% closed was 297 days in fiscal 2012. Seventy percent of PMA submissions were approved in fiscal 2012, but that number jumped to 85% the following year and stood at 74% for the 1st 6 months of fiscal 2014, according to the report (PDF).