FDA Moves to Streamline the De Novo Review Process

The U.S. Food and Drug Administration issued draft guidance on Oct. 3 in an effort to update the de novo review process for certain low- to moderate-risk medical devices. The document offers a new pathway for concurrent submission to the 510(k) and de novo clearance processes.

Originally passed by Congress in 1997, the de novo process was created for novel devices that fall short of having a “substantially equivalent” device on the market, and thereby unable to be cleared through the 510(k) process. Devices are only considered for the de novo clearance process—which has been underutilized, according to the FDA—after rejection through the 510(k).

The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements. The process could decrease the process time by as much as 90 days, according to the agency, and provides clarity for manufacturers on the suitability of a device for the de novo process.

“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” said Jeffrey E. Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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 guidance outlines two pathways for the de novo process. It can be initiated with a pre-de novo submission” (PDS) or with a 510(k) submission.

A PDS is recommended when it is believed there is no predicate for the device and is considered of low to moderate risk. Otherwise, manufacturers can submit a de novo petition if no substantial equivalent is found through a 510(k) submission. The FDA provided flowcharts on its website to explain the process of both de novo submission processes. The draft guidance is part of a list of 25 items from the FDA’s recent “Plan of Action” to
improve the 510(k) process.

Revision of the de novo process also was included by the Institute of Medicine (IOM) in its highly controversial 510(k) audit.According to the IOM recommended that the FDA explore whether a modified version of the de novo process could replace the 510(k) pathway.

“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 IOM. “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 the draft guidance. The public comment period will be open for 90 days after Oct. 3.