NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued draft guidance for new medical devices that have low to moderate risk but do not fit the criteria for 510(k) clearance in an effort to update and streamline a process that one FDA official called "cumbersome."
Generally, makers of low- to moderate-risk devices, including diagnostics, must obtain 510(k) clearance in order to market the device by demonstrating it is equivalent to an existing product already on the market. The de novo program was created in 1997 for those low- to moderate-risk devices that don't have equivalent devices already being legally marketed.
But while "FDA has reviewed and granted a number of de novo petitions since the 1997 legislation, the program has been under-utilized because of process inefficiencies," FDA said in a statement.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, added, "Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency. Creating a pathway for concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients."
The draft guidance outlines a process for a device manufacturer to be able to submit concurrently for 510(k) as well as de novo clearance, shortening the time for FDA to make a decision by up to 90 days while also providing clarity to manufacturers on when a de novo submission is suitable for a device, FDA said.
The new guidance creates a pre-de novo submission process, by which the agency would issue within 60 days of receiving all required information a suitability letter specifying whether the device qualifies for a de novo review. If it does, the manufacturer would then concurrently submit for a de novo review and a 510(k) review.
Manufacturers will also be able to file under the current system, which calls for submission of a device for 510(k) clearance. If FDA determines the device to be "not substantially equivalent," the manufacturer could then apply for a de novo review.