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  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 can help TAP participants better understand potential challenges related to adoption of and patient access to their innovative devices. Input from non-FDA parties may have significant value in helping TAP participants increase efficiencies throughout a device’s design development, during clinical trials, and planning for market adoption and patient access. Non-FDA party 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 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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