TAP Collaborating Partner
Stroke Recovery Foundation is pleased to announce that it has been selected as a Collaborating Partner in the FDA Total Product Life Cycle Advisory Program (TAP)
TAP Vision and Thought Process
The Total Product Life Cycle Advisory Program (TAP) Pilot is intended to foster early interactions FDA facilitates between device manufacturer participants and non-FDA stakeholders. FDA intends for TAP advisors like Stroke Recovery Foundation to help ensure the sustained success of the Breakthrough Devices Program for innovative devices.
The vision for Total Product Life Cycle Advisory Program (TAP) is to help spur more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.
The Food and Drug Administration (FDA) is encouraging “early, frequent, coordinated stakeholder interaction” to speed and achieve patient access to breakthrough devices as part of the new Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.
American Brain Coalition Role
The FDA has designated the American Brain Coalition (ABC) to assist in identifying interested stakeholders like Stroke Recovery Foundation who advise in the Neurological and Physical Medicine space. ABC will facilitate engagement between brain communities and other stakeholders within the FDA TAP Pilot. As a liaison and convenor, ABC will ensure a more meaningful range of stakeholders, and the lived experiences of patients and their families, are included in the important conversations and decision-making processes of TAP.
For more information, please contact Stroke Recovery Foundation by emailing Founder Bob Mandell at Bobm@StrokeRF.org.
