FDA: PMA approvals hit record high in fiscal 2015

The FDA this month said it approved a record 98% of the pre-market approval applications submitted for medical devices during fiscal 2015, its highest rate for the last 15 years.

The federal safety watchdog said it approved 86% of the PMAs submitted in fiscal ’14. The rate for the ’15 year, which ended Sept. 30, is the FDA’s highest PMA approval rate since 2001.

The FDA last year also got faster at approving PMAs, which cover high-risk, Class III devices, posting its lowest average time to decision since 2000 at 262 days. That’s a 39.4% improvement over last year, when it took an average of 432 days to get a PMA through the agency and just 10 days more that the 252-day low marked a decade and a half ago.

As for the less-stringent 510(k) process, for less-risky devices, the FDA said it deemed 85% of clearance applications “substantially equivalent” to their predicate devices, up 1% from fiscal 2014. The agency also greatly improved its time to 510(k) decision, slashing it 24.6% to 95 days compared with 126 days during the prior fiscal year.

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