FDA releases draft guidance on de novo review
The FDA issued draft guidance Oct. 3 updating the de novo review process for certain low to moderate risk medical devices, offering a new pathway for concurrent submission to the 510(k) and de novo clearance processes.
Passed by Congress in 1997, the de novo process was created for novel devices that fall short of having a “substantial equivalent” currently on the market, hence unable to be cleared through the 510(k) process. Devices are only considered for the de novo clearance process—which to date 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The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements.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 administration, 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, MD, 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, according to the FDA. 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 has 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 The draft guidance is part of a list of 25 items from the FDA’s Plan of Action to improve the 510(k) process.
Passed by Congress in 1997, the de novo process was created for novel devices that fall short of having a “substantial equivalent” currently on the market, hence unable to be cleared through the 510(k) process. Devices are only considered for the de novo clearance process—which to date 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The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements.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 administration, 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, MD, 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, according to the FDA. 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 has 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 Plan of Action to improve the 510(k) process.