The FDA has proposed new guidelines for the de novo clearance process that the agency says could shave 90 days off approval period of some devices. Currently, only devices that have already been rejected in the 510(k) process are eligible for de novo clearance.
The new process would allow developers to file a pre de novo submission for devices that are novel but low-risk to get early feedback. This process would ensure applications are complete, explains DOTmed News. Also under the new guidelines, companies could file joint 510(k) applications to avoid future delays that result when the agency rules a device is not substantially equivalent to one already on the market.
"Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency," said CDRH head Dr. Jeffrey Shuren in a statement. "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 agency will take comments on the proposed plan for the next 90 days.