FDA Expands TAP Pilot Program
The FDA's Total Product Life Cycle Advisory Program (TAP) Pilot now includes the Global Spine Initiative. This aims to foster collaboration among regulators, clinicians, and industry early in device development, with the goal of accelerating the path from concept to patient use.
The FDA's TAP Pilot Program, run by the Center for Devices and Radiological Health (CDRH), aims to accelerate the development of safe and effective medical devices. The program facilitates early and strategic communication between the FDA and medical device manufacturers. This voluntary program intends to bring innovative new devices to market faster. The TAP Pilot is being implemented using a phased-enrollment approach. In 2023, the pilot soft launched with 15 cardiovascular devices. The FDA plans to continue expanding the program to include more devices and different areas of health technology through 2027. The Global Spine Initiative (GSI) joining the TAP Pilot as a non-FDA party signals the FDA's intent to include a diverse range of expertise. GSI, co-chaired by Dr. Reginald Davis and Dr. Anthony Giuffrida, is a collective of spine leaders. GSI’s Doug Beall, MD, noted the value of cross-specialty engagement in helping innovators navigate clinical considerations. The GSI was established to advance a more coordinated approach to spine care.
