The Food and Drug Administration issued draft guidance that aims to streamline the agency's de novo review process, which has been traditionally used for low- to moderate-risk devices that do not meet requirements to be cleared by the 510(k) review process.
FDA offers guidance on streamlining device reviews
The FDA said in the Sept. 30 guidance that it would create a pathway for manufacturers to submit 510(k) and de novo petitions at the same time, rather than make manufacturers wait for the agency to deem a device “not substantially equivalent” to another device on the market.
The combined submissions could trim up to 90 days from the process, according to the FDA.
The 510(k) process, which is also called pre-market notification, is used by the FDA to clear low- to moderate-risk medical devices that are able to demonstrate they are “substantially equivalent” to other devices already on the market. The de novo process is used for low- to moderate-risk medical devices that are not comparable to other devices on the market.
“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a news 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.”
The Advanced Medical Technology Association, the trade group that represents device manufacturers, said in a statement that the FDA's proposal to allow manufactures to submit de novo and 510(k) petitions at the same time “may be a good start to streamlining the de novo process.”
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