Almost 90% of PMA Applicants Received Major Deficiency Letter on First FDA Review Cycle in 2016

Posted 09 September 2016 By Zachary Brennan

New data from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) show that through the first six months of 2016, 89% of premarket approval applications (PMAs) received a major deficiency letter in the first review cycle.

Though there’s only been six months this year, the figure is a historic high and more than double the 40% of PMAs that received such a letter in 2000, according to statistics released in the Quarterly Update on Medical Device Performance Goals as part of the third iteration of the Medical Device User Fee Act.


And despite these deficiencies, FDA data show the agency is at near-historic lows in the amount of time it’s taking to come to a decision on a PMA.


In that shortening period of time, the agency is still approving close to 90% of all PMAs for the first nine months of 2016, which is still slightly down from the 95% approved in 2015.


Quarterly Update on Medical Device Performance Goals ----MDUFA III CDRH Performance Data ---- Action through 30 June 2016

Share this article:

Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: MDUFA, PMA approvals, major deficiency letters

Regulatory Exchange: Latest Updates From the Community