Total Product Life Cycle Advisory Program (TAP)

UPDATE: October 7, 2026

As of October 7, 2026, there are 159 devices enrolled in the FDA’s TAP Pilot.

On July 1, 2026, TAP expanded to accept enrollment requests across all Offices of Health Technologies (OHTs) for Breakthrough-designated and Safer Technologies Program (STeP) devices that meet TAP enrollment criteria described below. 

On April 23, 2026, the Centers for Medicare and Medicaid Services (CMS) and the FDA announced a new Medicare coverage pathway: the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. RAPID will accelerate beneficiary access to eligible devices with Breakthrough Designation. More details about the RAPID pathway posted on August 7, 2026, are available here.

For TAP innovators with devices currently enrolled in the TAP Pilot, those with Breakthrough-designated devices not currently enrolled in the TAP Pilot, and/or those interested in pursuing RAPID, read more here.

TAP: Medical Device Accelerator

The FDA’s Center for Devices and Radiological Health (CDRH) launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. The TAP Pilot is one of the commitments between the FDA and industry as part of the MDUFA V reauthorization. 

TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and by facilitating engagement with other key parties for developers of devices of public health importance. To achieve this goal, a dedicated cadre of FDA TAP advisors proactively provide solutions-focused engagement that is tailored to each TAP innovator’s needs in advancing devices to market and patient access.

Feedback or questions about TAP may be submitted to TPLC-Advisory-Program@fda.hhs.gov.

Related Information

• TAP Independent Assessment Report – December 9, 2025 [PDF - 1.1 MB]
• TAP Pilot Engagement Tips (resource) 
• CDRH Statement – July 1, 2024
• CDRH Statement – October 2, 2023
• CDRH Statement – October 11, 2022
• Federal Register: Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot, October 11, 2022

More Information about TAP

TAP Overview

TAP advisors facilitate engagements with FDA and non-FDA parties that can help program participants identify strategic options to streamline the path to patient access to their devices.

TAP Enrollment & Expansion

The FDA evaluates device enrollment into the TAP Pilot based on criteria consistent with the MDUFA V commitment letter.

TAP Facilitates Engagement

Early, proactive, and solution-oriented engagement can help TAP innovators better understand potential challenges related to adoption of and patient access to their innovative devices.