The FDA grants Breakthrough Device Designation to devices that meet all of the following criteria:

Core Requirements:

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
2. The device meets at least one of the following:
   • Represents breakthrough technology
   • No approved or cleared alternatives exist
   • Offers significant advantages over existing alternatives
   • Device availability is in the best interest of patients

Our Process:

Week 1: Discovery and Eligibility Assessment

• Kick-off meeting with your team
• Review device specifications, clinical data, and competitive landscape
• Assess eligibility against all eight BDD criteria
• Identify gaps in available evidence or documentation
• Deliverable: Eligibility assessment memo with go/no-go recommendation

Week 2: Strategic Positioning and Device Description

• Identify strongest arguments for unmet medical need and clinical benefit
• Map comparable devices and articulate differentiation points
• Draft comprehensive device description and intended use statement
• Develop breakthrough technology justification (if applicable)
• Deliverable: Device description document and positioning strategy

Week 3: Evidence Compilation and Application Development

• Compile supporting literature and clinical evidence
• Document preliminary development and testing plan
• Write comprehensive BDD request demonstrating:
  • Life-threatening or irreversibly debilitating condition
  • More effective treatment or diagnosis vs. standard of care
  • Breakthrough technology argument
  • Absence of alternatives or significant advantages
• Deliverable: Draft BDD application for client review

Week 4: Finalization and FDA Submission

• Incorporate client feedback on draft application
• Prepare FDA eSTAR package and all required attachments
• Quality review and final approval
• Submit to FDA
• Deliverable: Complete FDA submission with confirmation receipt

Post-Submission:

• FDA typically responds within 60 days with grant or denial
• If granted: We help you leverage BDD for investor communications and regulatory planning
• If denied: We pivot to alternative regulatory strategies (covered under our guarantee)

Pricing depends on your device and scope. Contact us for a custom quote.

FDA typically responds within 60 calendar days of submission with a grant or denial decision.

Yes. Many companies issue press releases upon BDD grant. It signals FDA prioritization and regulatory momentum-both strong messages for investors and strategic partners.

No. BDD accelerates and prioritizes your review, but you still need to meet FDA's safety and effectiveness standards. However, the interactive review process significantly reduces regulatory risk.

If denied, you still have your standard regulatory pathway (510(k), De Novo, or PMA). We'll pivot immediately to optimize that strategy. Our guarantee covers this scenario.

Absolutely. We frequently collaborate with in-house teams and external consultants, particularly on AI/ML and software-specific aspects of BDD applications.

BDD is US-specific, but it signals regulatory credibility globally. We focus exclusively on FDA to maintain deep expertise, though we have international partners for CE mark, Health Canada, etc.

Book a 30-minute assessment call. We'll evaluate your device against BDD criteria and recommend the best path forward-whether BDD or an alternative strategy.