FDA metrics – device fees ups, approvals up, review times down

FDA DEVICE FEES AND APPROVALS UP, REVIEW TIMES DOWN (Orthopedics This Week)
Medical device companies paid the FDA $96.8 million in user fees during fiscal year 2013, up 48% from the previous year.
What is industry getting for that extra money? For one thing, according to an agency quarterly report, the percentage of premarket approval (PMA) applications approved by the agency grew from 59% in 2010 to 74% so far in 2014. The average time to get a decision for a PMA has dropped over 30% from a high of 464 days in 2009 to 297 in 2012. The agency has also decreased the PMA backlog by over 45% fr...