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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)
  6. How TAP Facilitates Engagement with Non-FDA Parties
  1. Total Product Life Cycle Advisory Program (TAP)

How TAP Facilitates Engagement with Non-FDA Parties

Early, proactive, and solution-oriented engagement from non-FDA parties may have significant value in helping TAP participants increase efficiencies during device development, clinical trials, and while planning for market adoption and patient access. Such engagement can help TAP participants to streamline the path from concept to commercialization, toward the goal of ultimately increasing patient access to high-quality, safe, effective, and innovative medical devices.

TAP Pilot Engagement Tips cover

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TAP participants may consider requesting strategic input from non-FDA parties in areas such as:

Patient Engagement

  • Identify unmet patient needs.
  • Understand patients’ perspectives about benefit-risk tradeoffs.
  • Assess the barriers patients encounter when managing health conditions.
  • Gauge how new technologies may fit into daily management of health conditions.
  • Incorporate human-centered design features.
  • Consider patient-centered clinical study designs.

Clinical Evidence Development

  • Define intended use and indications.
  • Develop plans on how to obtain clinical evidence.
    • Evidence strategies and roadmap
    • Clinical study design and endpoints
    • Publication strategies
    • Post-market registry planning
  • Understand perspectives on society practice guidelines.

Clinical Practice and New Technology Adoption

  • Assess current clinical practice and patient needs.
  • Identify new technologies’ impact on current clinical workflow.
  • Understand factors affecting health care providers’ willingness to modify clinical practice.
  • Gain feedback on early-stage device designs.
  • Explore multi-society collaboration approaches.

Reimbursement

  • Gain insight on coding strategies and creating new codes.
  • Obtain provider feedback on establishing payment levels.
  • Plan evidence generation and payer coverage strategies.

TAP does not design, coordinate, convene, or run engagements between TAP participants and non-FDA parties. Instead, TAP facilitates a way for TAP participants to request early interactions with non-FDA parties so they may better understand the patient perspective in developing medical devices, health care provider needs for market adoption, and payer needs for coverage and reimbursement.

TAP Non-FDA Parties

The following is a listing of organizations who have agreed to be listed on our website and to provide TAP participants with strategic input on their innovative device:

If you are a patient organization, payer group, professional society, or other relevant organization that is interested in learning more about becoming a TAP non-FDA party, email TPLC-Advisory-Program@fda.hhs.gov.

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