Following the release of draft guidance that proposed expanding the device changes that would be eligible for the special 510(k) program, the Food and Drug Administration (FDA) has launched a pilot to put the planned changes into use. From 1st October 2018, all special 510(k)s that are submitted to FDA’s Center for Devices and Radiological Health will be evaluated under the pilot.
The draft guidance outlines the FDA’s aim to increase the number of 510(k) submissions that could be submitted under the program, which should enable a least burdensome approach for expedited reviews and subsequent clearances. The guidance proposes to include certain device modifications and labelling changes compared to the 1998 program design.
The FDA has stated in the guidance that there are three eligibility factors to help manufacturers determine whether a device is appropriate for participation. These factors include a proposed change being made by the manufacturer that obtained 510(k) clearance for the device, performance data are unnecessary or well-established methods for evaluation the change are available and the ability to review these data in a summary or risk analysis format.
The FDA stated that the overall goal of the pilot is to “determine whether updated factors for eligibility in the Special 510(k) Program will improve the FDA staff’s efficiency in reviewing 510(k) submissions”.
To read more about the FDA pilot on proposed expansion of special 510(k) program, please click here.