FDA Total Product Life-Cycle Advisory Program (TAP) Pilot

FDA Total Product Life Cycle Advisory Program (TAP) Pilot

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.

The vision for TAP is to help spur more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance. Medical devices range from common medical supplies (bandages, hospital gowns) to complex instruments that help save and sustain life (deep brain stimulation, vagus nerve stimulation, transcranial magnetic stimulation).They include tools that aid in the detection of disease (MRIs, in vitro diagnostics) and digital technology that is driving a revolution in health care (medical apps, surgical planning tools, closed loop drug delivery devices).

The TAP Pilot is intended to foster early interactions FDA facilitates between device manufacturer participants and non-FDA stakeholders. FDA intends for TAP to help ensure the sustained success of the Breakthrough Devices Program for innovative devices.

ABC's Role

Through generous grant support from the Dana Foundation, the American Brain Coalition has partnered with the FDA in identifying interested stakeholders in the Neurological and Physical Medicine space. ABC facilitates engagement between brain communities and other stakeholders within the FDA TAP Pilot. As a liaison and convenor, ABC ensures 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.

How to Participate

Your initial interaction is informational and intended for organization's to educate FDA about the organization's area(s) of potential interest, engagement ability/limitations, communication platforms, membership base, and other areas, to facilitate potential outreach on relevant Breakthrough Devices. ABC will work with you to gather the relevant information using key questions FDA has developed.

Stakeholder engagements with device manufacturers are anticipated to occur early in the device development process when manufacturers have not yet intitiated a pivotal study and are seeking meaningful patient input.

Furterther Information