The U.S. Food and Drug Administration (FDA) has issued a draft guidance for manufacturers that updates and streamlines the evaluation of automatic class III designation, the de novo review process used for certain innovative, low- to moderate-risk medical devices that do not meet the requirements for clearance under the better known 510(k) review process, the agency announced.
Before manufacturers may market most low- to moderate-risk medical devices, such as certain catheters or diagnostic imaging devices, they must obtain FDA clearance of a premarket notification or 510(k).
Generally, 510(k) submissions must demonstrate that the new device is substantially equivalent to another, legally marketed medical device that is also low- to moderate-risk.
However, some low- to moderate-risk medical devices are novel and not comparable to an already legally marketed device. Legislation passed by Congress in 1997 created the de novo process for these types of devices.
Currently, devices are only considered for the de novo program after the agency rejects a 510(k), establishing that the device is not substantially equivalent to another legally marketed device.
Although FDA has reviewed and granted a number of de novo petitions since the 1997 legislation, the program has been underutilized because of process inefficiencies.
The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements, trimming up to 90 days from the process and fostering more efficient, early interaction between manufacturers and the FDA.
The guidance also 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," stated Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a press release. "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."
This draft guidance is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations launched earlier this year to improve the predictability, consistency, and transparency of the agency's premarket review programs.
The FDA is seeking comments about the draft guidance. For more information and how to submit comments, visit the FDA website.
