The Global Spine Initiative has joined the FDA’s Total Product Life Cycle Advisory Program Pilot as a non-FDA party.
The FDA TAP Pilot brings regulators, clinicians and other stakeholders together early in the development process to support medical technologies, according to a March 9 news release shared with Becker’s. The GSI, co-chaired by neurosurgeon Reginald Davis, MD, and interventional pain management physician Anthony Giuffrida, MD, is a collective of spine leaders.
“GSI was established to help advance a more coordinated and forward-looking approach to spine care,” Doug Beall, MD, leader of the GSI TAP program, said in the release. “Our inclusion in the TAP Pilot underscores the value of cross-specialty engagement in helping innovators navigate the broader clinical and real-world considerations that influence whether meaningful technologies ultimately reach patients.”
The designation reflects GSI’s emerging role in advancing collaboration in spine care. GSI also hosts its own initiatives including its Think Tank 2.0 and forum with the North American Spine Society.
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