The FDA released new draft guidance aiming to streamline the de novo device review process by allowing applications to be submitted concurrently with 510(k) bids.
The guidance outlines a pathway for device makers to submit 510(k) applications and de novo applications at the same time, potentially trimming up to 90 days off the review process.
"Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency," head of the FDA’s center for Devices & Radiological Health Dr. Jeffrey Shuren, M.D said in prepared remarks. "Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients."
The draft guidance is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations, launched earlier this year to improve the watchdog agency’s review processes.
Revision of the de novo process was also one of the recommendations made by the Institute of Medicine in its controversial 510(k) audit.
The IOM review suggested that the FDA "explore whether a modified version of its de novo process could replace the 510(k) process."
"The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared," according to the institute. "Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program."
The FDA is seeking comment on its latest draft guidance, and the public comment period is open for the next 90 days.
