FDA Approving Devices Faster
Thursday, March 26, 2015
Griping about FDA approval times has long been a favorite pastime of medical device executives, but if 2014 is any evidence, that complaint may soon disappear. FDA is getting faster at approving devices, and the speed up can’t yet be chalked up to accelerated approval pathways.
It took an average 17.6 months for a first-time premarket approval (PMA) in 2014, compared to almost twice as long in 2013, according to the findings of a report from EP Vantage, the editorial arm of market intelligence firm Evaluate Ltd. There were also more devices approved through the PMA and humanitarian device exemption pathways in 2014, with 33 approvals versus 23 in 2013.
The most common therapy areas for these first-time PMA devices were cardiology—such as Medtronic’s CoreValve transcatheter aortic valve for extreme risk and high risk patients—and in vitro diagnostics.
Lately, FDA officials have emphasized the agency’s focus on speeding approvals for both drugs and devices. At a Senate Health, Education, Labor, and Pensions (HELP) Committee meeting in early March, FDA commissioner Margaret Hamburg pointed out,“today, FDA approves drugs faster on average than all other advanced nations: 40 days faster than Japan; 70 days faster than Canada; and 174 days faster than Europe. And FDA has made substantial improvements in efficiency of medical device reviews as well,” she said.