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FDA Breakthrough Devices & Special Access Pathway Services

Accelerate Market Access for Innovative Medical Devices with FDA Breakthrough & Expanded Access Support

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What is the Breakthrough Devices Program?

The Breakthrough Devices Program is an FDA initiative that expedites the development, assessment, and review of medical devices and device-led combination products that provide more effective treatment or diagnosis of serious or life-threatening conditions.

Benefits of the program include:

  • Priority review of marketing submissions, including 510(k), De Novo, and PMA
  • More frequent and interactive engagement with FDA reviewers
  • Early and consistent feedback to help manage development risks
  • Eligibility for CMS coverage under the Transitional Coverage for Emerging Technologies (TCET) pathway

What is the Expanded Access Pathway?

Also referred to as “Compassionate Use,” the FDA’s Expanded Access Program allows patients with serious or life-threatening conditions to access investigational devices outside of clinical trials.

This pathway is typically used when:

  • No comparable or satisfactory alternative therapy options are available
  • The device shows promise based on preliminary data but is not yet approved
  • A time-sensitive or urgent intervention is required

dicentra supports medical device manufacturers by preparing and submitting expanded access requests, ensuring alignment with FDA expectations and coordination with institutional review boards (IRBs).

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Our Breakthrough & Special Access Services

Regulatory Strategy & Eligibility Assessment

  • Evaluate product fit for Breakthrough Designation or Expanded Access
  • Identify regulatory risks, data requirements, and timeline expectations

Breakthrough Designation Request Preparation

  • Author and submit the Breakthrough Device Request package
  • Clearly demonstrate how your product meets FDA criteria for designation

Expanded Access Submissions

  • Prepare and submit FDA Form 3926 for individual patient access
  • Coordinate IRB submissions and physician sponsor documentation

FDA Meeting Support

  • Plan and manage Q-Sub meetings and pre-submission interactions
  • Prepare briefing packages and key discussion strategies

Pathway Transition Planning

  • Convert Breakthrough status into successful marketing submissions (510(k), PMA, De Novo)
  • Ensure alignment on clinical, nonclinical, and manufacturing data with FDA expectations

Why Choose dicentra?

  • Over 20 years of experience guiding clients through FDA regulatory pathways
  • Multi-disciplinary team of regulatory strategists, medical writers, and clinical affairs professionals
  • Deep expertise in both U.S. and international regulatory frameworks
  • Known for responsive, hands-on support and strong FDA relationships

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