Review Times Improving at FDA

The FDA has improved its performance in reviewing device applications since 2010.

Margaret Hamburg, M.D., the agency’s commissioner, told Congress on March 13, 2014 that since that date, the agency has achieved:

• 27% decrease in the backlog of lower device applications
• 10% decrease in average total review time
• 43% decrease in higher risk devices backlog
• 32% decrease in average total review time

Hamburg said the agency is at the “cutting edge in terms of review and approval of new products, ” compared to the rest of the world. “If you look at drugs approved in recent years, I think about three-quarters of them were approved in the United States first and on devices, apart from the highest risk devices, we are I think at par with comparable other countries in terms of review times. We do ask for more clinical data often on the higher risk devices. But, I think there’s some urban mythology about where we stand in comparison to review times and leadership.”

Under the most recent user fee agreement (MDUFA III) with the device industry, the FDA will collect almost $600 million in fees over five years. The agency plans to hire an additional 200 full-time employees over that time to speed up review times. Hamburg added that since October 1, 2013, the agency has already hired 90 of those employees.

Janet Trunzo, senior executive vice president, technology and regulatory affairs of AdvaMed, told OTW on March 19, 2014:

“AdvaMed is encouraged by the progress FDA has made in meeting its commitments under the new user fee agreement, but we all recognize there is a long way to go. So far, the agency appears to be meeting its MDUFA III decision goals and commitments for substantive interactions with submission sponsors. Initial data from FDA shows marked improvement in total review times for PMAs [premarket applications] and modest improvement in total review times for 510(k)s compared to the historic highs seen in 2010. We look forward to continuing to work with the agency to ensure accountability under the new user fee agreement and continued progress toward improving the timeliness of reviews.