Neurological Devices Can Enter FDA Pilot Program in October

The FDA will allow manufacturers of neurological devices for treating or diagnosing conditions like Alzheimer’s disease and epilepsy to join a pilot program aimed at speeding up product reviews starting in October.

The Total Product Life Cycle Advisory Program, also known as the TAP Pilot program, will expand beginning Oct. 1 to include devices that fall under the Office of Neurological and Physical Medicine Devices, the Food and Drug Administration’s Center for Devices and Radiological Health said in an update Monday. The program is one of the commitments the FDA made in its user fee agreement with the medical device ...