News Feature | October 28, 2014

Have Medical Device Review Times Improved?

By Nick Otto

A new look at the FDA’s medical device review times from the California Healthcare Institute (CHI), in partnership with The Boston Consulting Group, points to a modest improvement in the agency’s review times.

Some key takeaways from the report include a reduction in the agency’s backlog of 510(k) approvals, particularly on the devices waiting more than 90 days. However, data from the report suggests that the 510(k) clearance time is not yet back on track, noting that in 2010 the time to clear was close to 60 percent longer than it was in 2000.

“The data in our report illustrates that Agency leadership has worked to get processes, internally and with industry, back on track,” said CHI president and CEO Todd Gillenwater, in a recent CHI press release. “But there is more work still to be done to ensure device regulatory review processes are best directed towards the Agency’s twin goals: protecting patient safety and promoting patient health through timely approval of and access to innovative medical technologies.”

The CHI also indicated that the report showed some positive light for premarket approval (PMA) applications.

“Data suggests that the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era,” CHI said of the report in its press release.

In reference to the report, the Regulatory Affairs and Professionals Society (RAPS) noted that PMA backlogs are also at some of the lowest levels in recent time, citing 52 backlogged applications in 2013 as compared to 93 in 2010.

In the organization’s press release, the CHI said that it worked closely some of the FDA’s leaders, including Center for Devices and Radiological Health (CDRH) director Jeff Shuren.

Shuren earlier this summer provided a status report, updating CDRH’s plans to improve its consistency and efficiency in reviewing devices, following an independent review of CDRH from Booz Allen Hamilton that made several recommendations including developing mechanisms to improve the agency’s decision-making consistency throughout the review process.

Emergo Group earlier this year published its own study on 510(k) review times, noting that on average it takes five months for a 501(k) submission to clear. The study pointed to a decline in approval times between 2006 and 2011, which then stabilized in 2012 and 2013.

“The FDA is a critical linchpin in the medical technology innovation ecosystem,” Gillenwater added in the CHI press release. “We produced this report to be a productive tool to continue to drive forward and communicate the real improvements we’ve seen at the FDA, while also being constructive in pointing to areas where there is still more to be done.