Washington E-Newsletter

Neurosurgery Partners with FDA for Breakthrough Device Innovation

Through its Drugs and Devices Committee, the AANS and the CNS are collaborating with the Food and Drug Administration (FDA) in its Total Product Life Cycle Program (TAP). The TAP pilot program is designed to provide participants with earlier and more frequent interactions with the FDA and more strategic engagement with non-FDA stakeholders to help spur rapid development and timely and widespread patient access to safe, effective, high-quality medical devices. This program will assist manufacturers of neurological devices in gaining approval — from concept to market — through the FDA’s Breakthrough Devices Pathway.

Thus far, the AANS/CNS Drugs and Devices Committee leaders have met with FDA TAP staff several times, including during the CNS Annual Meeting in Washington, DC.