July 1, 2024

The FDA is announcing that beginning October 1, 2024, the TAP Pilot will expand to include the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A). On January 1, 2025, the TAP Pilot will also expand to include the Office of Orthopedic Devices (OHT6).

To date, the FDA has enrolled 46 devices in the TAP Pilot.

TAP is currently accepting enrollment requests for medical devices reviewed by the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine (OHT5).

TAP: FDA’s Medical Device Accelerator

The FDA’s Center for Devices and Radiological Health (CDRH) has 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 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.

TAP was developed for patients and innovators by an FDA team with deep and diverse MedTech expertise, including:

  • FDA total product lifecycle regulatory expertise;
  • clinicians experienced in payer coverage policy, and an adviser to the American Medical Association CPT® Editorial Panel;
  • MedTech industry experience in both venture-backed and Fortune 500 companies across a wide range of areas, including research and development, marketing, operations, quality, and business development; and
  • physicians who sat on executive committees for and ran provider groups and held leadership positions in medical specialty societies.

Feedback or questions about TAP may be submitted to [email protected].

TAP Team

Dedicated TAP advisors, OPEQ review staff, and CDRH subject matter experts proactively work with participants to facilitate solutions-focused engagement and help identify approaches to advancing devices from concept to commercialization.

Opportunities to Meet the TAP Team

Please contact the TAP Team at [email protected] to learn about opportunities to meet members of the team.

Related Information

Sub-Topic Paragraphs

TAP Overview

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

TAP Enrollment & Expansion

The FDA evaluates device enrollment into TAP based on the following 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.