FDA’s Approval Rate for PMAs Hits Record High in FY2015

CDRH approved 98 percent of the premarket approval applications that it received for medical devices in fiscal 2015, marking an all-time high since the start of the Medical Device User Fee Amendments.

It’s the FDA’s highest rate since 2001, soaring since the all-time low of 59 percent in 2010 and well above the second-highest rate of 90 percent in 2005, according to a quarterly update on performance goals for MDUFA III.

The 98 percent approval rate is only reflective of those submissions that have received a final MDUFA decision, points out FDA spokesman Jeff Ventura.

“There are still a number of submissions from FY2015 that haven’t yet reached a final MDUFA decision, so that number will likely change once we have closed out the entire cohort,” he tells IDDM.

Still, the FDA believes higher approval rates are the result of an increase in the amount of interactive reviews that are helping the agency resolve issues during the review process, says Ventura.

PMAs also are getting approved more expeditiously, with CDRH cutting the average decision time significantly from 432 days in 2013 to 262 days in 2014, according to the report.

In recent years, the FDA has implemented several changes to its policies and the PMA program itself meant to help expedite device reviews.

These changes include streamlining the clinical trials program, facilitating and encouraging the use of innovative clinical trial designs and incorporating a patient-centric benefit-risk framework into PMA device reviews, says Ventura.

The agency also has been working with manufacturers through the pre-submission process to facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process, he adds.

Read the MDUFA III performance report here: www.fdanews.com/11-15-FDA-MDUFA.pdf. — Jonathon Shacat