Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA) pilot program that aims to shorten the time it takes novel devices to reach patients, a nonprofit advocacy group told the agency. The industry lobby group AdvaMed meanwhile called on the agency to select an office with limited experience with the Breakthrough Devices Program.
In comments submitted to the agency, the American Brain Coalition (ABC) asked FDA to expand its voluntary Total Product Life Cycle (TPLC) Advisory Program Pilot, or TAP, to include devices that treat an array of brain conditions. The agency says TAP will streamline the device clearance process and will allow for earlier and more frequent engagement between developers and FDA’s Center for Devices and Radiological Health (CDRH), among other benefits…
