Report: FDA PMA approval rate hits record high

The FDA’s approval rate for premarket approval applications has hit record highs, according to a report from the Regulatory Affairs Professionals Society.

According to the group, the Agency has approved “nearly every” PMA application it received in 2015, and gave possible credit for the spike to the FDA’s improved assessment of PMA deficiencies earlier in the review process.

“The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005,” the report states.

The data comes from a quarterly update to the Medical Device User Fee Amendments released on Wednesday, the group said.

The RAPS group said PMAs are being approved with record speed, cutting average time to a decision by nearly half between 2013 and 2014, from 432 days to 262 days.

The federal watchdog wasn’t optimistic, and said it expects the average time to increase, RAPS said.

This year, nearly 2/3rds of all PMAs received a major deficiency letter on their first FDA review cycle. That’s 10% higher than 2014 and slightly lower than the numbers between 2007 and 2013, RAPS said.

PMA applications that require panel reviews also saw average time to decisions fall to levels lower than the Agency has seen since 2007, RAPS reported.

The number of pending PMAs are also near all-time lows, though the FDA said the slight increase is due to higher number of PMAs filed this year.

FDA 510(k) applications stayed on par with previous years, the group reported, with average time to decisions consistent with prior years.

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