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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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)
  6. TAP Overview
  1. Total Product Life Cycle Advisory Program (TAP)

TAP Overview

 

A triangular diagram showing the relationships between all parties and their contributions to the TPLC Advisory Program (TAP), which result in high-speed interactions, earlier, enhanced engagement at key touchpoints, and TAP facilitated engagements. Left place in the triangle: FDA interactivity with device review teams and other FDA staff. Right place in the triangle: Market adoption and patient access from reimbursement experts and payers, specialty societies and providers, and patient organizations. Top of the triangle: the TAP participant. Middle of the triangle: the FDA TAP advisor who facilitates non-FDA party strategic input, coordination with FDA and facilitates access to regulatory expertise throughout the FDA process.

FDA TAP Advisors: Proactive and Strategic Engagement

TAP advisors facilitate engagement with FDA and non-FDA parties that can help program participants identify strategic options to streamline the path to patient access to their devices. With TAP, the FDA is striving to play a more active part in supporting patient access innovative, safe and effective devices.

In their roles at the FDA, TAP advisors:

  • Offer expertise across many fields including regulatory, clinical, and quality management.
  • Help identify key challenges that may hinder the path to U.S. marketing authorization through proactive and holistic discussions.
  • Facilitate discussions with non-FDA parties that can help TAP participants best strategize on actionable solutions for potential challenges related to market adoption, clinical use, and patient access.

FDA Interactions: A New Paradigm of Speed and Collaboration

Through TAP, CDRH is applying lessons learned from the COVID-19 public health emergency to move quickly and take a more fluid and informal approach to interacting with the MedTech industry. TAP is also designed to offer increased predictability and transparency in the regulatory process for participating companies.

Multiple accelerated FDA engagement options are available to TAP participants, including:

  • Regular informal touch-base meetings with TAP advisor and review teams.
  • Teleconferences on requested topics within 14 days.
  • Written feedback on requested topics within 40 days (accelerated to 21 days for biocompatibility or sterility topics).

Patient Access: Pursuing Our Public Health Mission

TAP strives to accelerate patient access to high-quality, safe, effective, and innovative medical devices. TAP can help participants prepare for the road ahead and consider the full path to market and patient access for their enrolled devices. TAP advisors also act as innovation ambassadors and can help identify non-FDA entities from the MedTech ecosystem who may provide input to TAP participants. Early insights and non-FDA party input gained through TAP can help increase the likelihood that a high-quality, safe, and effective device ultimately reaches patients.

Non-FDA Parties include:

  • patient organizations
  • medical specialty societies and associations
  • reimbursement experts and payers

TAP Limitations

TAP focuses on identifying risks, challenges, and potential solutions during device development, while facilitating interactions between TAP participants and non-FDA parties to support more widespread patient access to high-quality, safe, effective, and innovative devices.

TAP does not:

  • Determine what kind of risks are acceptable.
  • Decide what activities should or should not be financed.
  • Formulate or execute strategies.
  • Replace professional management or consultants.

Ultimately, TAP participants must decide on their own strategies, evidence needs, and execution plans.

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