Q2 MDUFA Report: PMA Approvals Down Slightly
The rate of premarket approvals is down slightly in 2016, according to the FDA’s quarterly report tracking Medical Device User Fee Act performance.
So far this year, 86 percent of premarket approval applications (PMAs) have been approved, compared with a high of 95 percent in 2015. PMAs were approved at a rate of 85 percent and 86 percent in 2013 and 2014, respectively.
The number of substantive interactions for PMA originals and panel track supplements appears to be down compared with last year. The agency conducted 16 substantive interactions in the first two quarters of this year, compared with 68 for all of fiscal 2015.
The report notes the average number of days to substantive interactions has dropped since last year — from 92 in 2015 to 90 so far this year. This is in line with the agency’s goals under MDUFA III, to reduce both the time and cost for market approval of a device. In fiscal 2013, the average number of days was 110.
The report did not have figures for 2016 on the average number of FDA days to make a MDUFA III decision. However, this has dropped from a high of 359 in fiscal 2013 to 206 in fiscal 2015 for PMA original and panel track supplements with panel review. During that same period, the number of days for applications without panel reviews went from 225 to 183.
The average number of industry days to a MDUFA III decision, with panel review, increased from 108 to 119 days for PMAs. For applications without panel review, the number dropped from 167 to 59 days.
For 510(k) submissions, 83 percent were found to be substantially equivalent so far in 2016. This is a slight drop from 85 percent for 2015 but an increase over 2013’s rate of 79 percent.
MDUFA III decisions have taken the agency an average of 55 days in fiscal 2016, so far, compared with 72 days in fiscal 2015. The average number of industry days during the same period went from 50 to 11.
The number of substantive interactions also declined, from 3,441 in fiscal 2015 to 1,061 in FY 2016, so far.
The report did not include data, metrics, or goals on clinical laboratory improvement amendments or de novo requests, as those will be included in the FDA’s annual report. Also included in the annual report will be more information on the agency’s 510(k) metrics and goals.
The document is part of the FDA’s 2012 commitment under MDUFA III to release quarterly and annual reports on the program’s implementation. Following a third-party review of the agency’s performance in 2013, it identified several measures to bolster efficiency, the first stage of which should largely be implemented.
These measures include: mandatory, full staff training for three key IT systems that support MDUFA reviews; identifying better metrics and methods to assess review process training satisfaction; and a multi-pronged approach to five quality component areas that can help standardize process lifecycle management activities and improve review consistency.
The last component incorporates corrective and preventive action and continuous process improvement, resource management, document management and system evaluation.
As of March 31, the FDA had collected $110. 5 million in medical device user fees — 80 percent of an authorized $137. 6 million.