Posted 11 November 2015
By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to 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, according to a 371-page quarterly update on the Medical Device User Fee Amendments (MDUFA III) performance released Wednesday.
What’s more, FDA is approving the PMAs at record speeds. The average time to a decision was nearly cut in half between 2013 (432 days) and 2014 (262 days), though FDA said it expects both of those average times to increase.
One of the possible causes for the record high approval rate is that FDA is figuring out and informing companies earlier of deficiencies with their applications. Under the PMA review process, FDA can notify the PMA applicant via major/minor deficiency letters of any information needed by FDA to complete the review of the application.
In 2015, about two-thirds of all PMAs received a major deficiency letter on the first FDA review cycle, which is 10% higher than 2014, though slightly less than the number of letters sent between 2007 and 2013.
And even PMAs that need a panel review are seeing the average time to a decision fall to near 2007 levels.
In addition, the number of PMAs pending at the end of 2015 is hovering around the record lows set between 2012 and 2014, and FDA notes that the slight increase in 2015 reflects an increase in the number of PMAs filed.
510(k) Substantial Equivalence
As far as 510(k) applications, FDA’s determinations of substantial equivalence – meaning that a new device is substantially equivalent to a legally marketed device – remained on par with previous years:
FDA’s average time to a decision on a 510(k) application remained consistent with recent years past, as did the percent of 510(k)s with additional information requests on the first and second FDA review cycles.
Quarterly Update on Medical Device Performance Goals