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CDRH Provides Update on the Total Product Life Cycle Advisory Program Pilot

October 2, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

Today, the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is expanding to include devices reviewed in the Office of Neurological and Physical Medicine Devices (OHT5). 

TAP is a voluntary program intended to de-risk the medical device “valley of death” by providing industry with earlier and more frequent interactions, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more investment in and rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health.

Following a successful launch in January 2023, CDRH’s TAP Pilot has enrolled 12 Breakthrough Designated Devices in the Office of Cardiovascular Devices (OHT2). 

CDRH has recruited and brought on-board 21 subject matter experts to support TAP. These talented individuals bring with them a broad array of expertise, including device regulation, management consulting, business development, product introduction, marketing, research and development, manufacturing, venture capital, medical practice, and payer coverage policy including Common Procedural Terminology (CPT) coding and Relative Value Unit (RVU) determination. 

CDRH TAP advisors and OPEQ review staff have worked interactively to meet TAP sponsors where they are with their development efforts and proactively provide expert recommendations and advice on options and opportunities. TAP has helped device developers enrolled in the program make decisions quickly on topics, including prioritizing the TAP device within their larger business model, device design features, clinical trial design and execution, and pre-clinical testing, as well as to understand FDA marketing authorization pathways and requirements. TAP has established relationships with numerous professional societies, patient organizations, and payers to understand the expectations and evidence requirements, as applicable. These collaborators help TAP sponsors understand early in their evidence development the evidence likely required for broad and rapid patient and physician adoption. 

In FY24, TAP will continue to support products enrolled in FY23 and expand to enroll additional Breakthrough Designated Devices across OHT2 and OHT5, up to a total of 60 devices enrolled through FY24. TAP will expand the lessons learned during its soft launch in the first 9 months of 2023 to make the program even better for the new fiscal year. TAP looks forward to expanding our patient organization, professional society, and payer relationships into the neurological and physical medicine fields to facilitate even timelier and more widespread patient access to safe and effective medical devices.

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