Part of the latest user-fee agreement was a promise from the FDA that it would speed up the time it takes to rule on new devices. Keeping its word, the agency has unveiled a plan to improve response times for 510(k) applications.
The FDA published a guidance saying that by 2017, it plans to reduce the average wait period to 124 days for clearance applications, down from the current 150 days, Mass Device reports. The agency will work its way to that goal gradually, setting benchmarks of 135 days in 2013 and 2014, and 130 in 2014 and 2015.
As it stands, the FDA turns around 90% of its 510(k) applications within 90 days, but delays with that remaining 10% are driving up the average. The new rules are designed to change all that, mandating that FDA conduct preliminary acceptance reviews on applications within 15 days of receipt, moving straight into determining substantial equivalence.
The industry by and large supported the latest user-fee agreement, which doubled the charge to $595 million over 5 years, on the strength of the FDA's pledge to quicken its pace. To follow through on its promise, the FDA is authorized to use that money to expand its resources, human and otherwise, and devicemakers have thus far seemed optimistic that the agency will come through.
- read Mass Device's story
- here's the FDA guidance