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U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Total Product Life Cycle Advisory Program (TAP)
  1. How to Study and Market Your Device

Total Product Life Cycle Advisory Program (TAP)

 

There are currently 62 devices enrolled in the FDA’s TAP Pilot. 

On October 1, 2024, the Total Product Life Cycle Advisory Program (TAP) Pilot expanded to include medical devices reviewed by the Division of Ophthalmic Devices (DHT1A) and the Office of Radiological Health (OHT8). 

The TAP Pilot is now accepting enrollment requests for Breakthrough Designated devices reviewed by the:

  • Division of Ophthalmic Devices (DHT1A)
  • Office of Cardiovascular Devices (OHT2)
  • Office of Neurological and Physical Medicine Devices (OHT5)
  • Office of Radiological Health (OHT8)

On January 1, 2025, the TAP Pilot will expand to include the Office of Orthopedic Devices (OHT6).

TAP: FDA’s 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 participant’s needs in advancing devices to market and patient access.

The TAP Pilot team offers deep and diverse MedTech expertise and experience, including:

  • total product lifecycle regulatory expertise;
  • payer coverage policy, including advising the American Medical Association CPT® Editorial Panel;
  • MedTech industry experience in both venture-backed and Fortune 500 companies across functions such as R&D, marketing, operations, quality, and business development; 
  • operating physician provider groups and holding leadership positions in medical specialty societies, and
  • integrating patient insights to help inform more patient-centered product development, clinical study planning and execution, and market adoption.

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

Related Information


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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 participants better understand potential challenges related to adoption of and patient access to their innovative devices.


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