The medical device industry is constantly evolving, with transformative technologies on the horizon. However, market entry can be lengthy and complex. The FDA’s Breakthrough Devices Program offers a faster pathway for genuinely innovative devices that address critical unmet medical needs.

What Is Breakthrough Device Designation?

Established under the 21st Century Cures Act and codified in section 515B of the FD&C Act, the Breakthrough Devices Program is a voluntary pathway for select medical devices and device-led combination products. It applies to devices seeking PMA, 510(k), or De Novo marketing authorization and is intended to speed development, assessment, and review while ensuring safety and effectiveness.

Eligibility Criteria

To qualify for Breakthrough Device designation, a device must satisfy:

First Criterion

• Whether a Device Provides for “More Effective” Treatment or Diagnosis

• Whether a Disease or Condition is “Life-Threatening”

• Whether a Disease or Condition is “Irreversibly Debilitating”

Second Criterion

• Device Represents Breakthrough Technology

• No Approved or Cleared Alternatives Exist

• Device Offers Significant Advantages over Existing Approved or Cleared Alternatives

• Device Availability is in the Best Interest of Patients

Key Benefits of Designation

• Expedited Review: Priority review at pre-submission and marketing stages; enhanced developer-FDA communication; senior leadership engagement within FDA review teams

• FDA Collaboration: Interactive, frequent discussions on study design; potential for innovative clinical trial approaches, adaptive endpoints, and flexible data strategies

• Market and Strategic Advantage: Earlier patient access, competitive differentiation, enhanced investor appeal

Application Process Overview

Preparation Phase — Compile:

• Device description and intended use

• Preliminary clinical or analytical evidence demonstrating breakthrough potential

• Unmet need justification and alignment with FDA criteria

Submission Requirements

• Detailed device description

• Indications for Use

• Regulatory History

• Justification of which criterion is met

• Development plan and regulatory strategy

FDA Review Timeline: FDA aims to respond within 60 calendar days.

Post-Designation Expectations

Ongoing Communication

• Schedule frequent Q-Submission (Q-Sub) or pre-submission meetings

• Provide periodic updates as clinical evidence accumulates

• Adhere to agreed development milestones and timelines

Compliance and Quality Systems

• Maintain a robust quality management system (QMS) and documentation

• Track and document all FDA interactions

• Report significant changes, adverse events, or emerging safety issues promptly

Strategic Considerations

• Does your device truly target an unmet need in a serious disease area?

• Is there sufficient preliminary evidence to support a breakthrough designation?

• Is your team ready for intensive FDA interaction?

• Will the designation realistically shorten your overall path to market?

Conclusion

The FDA Breakthrough Devices Program remains a powerful tool for accelerating the path to market for truly transformative medical devices. Careful planning, strong preliminary evidence, and strategic FDA engagement are key to leveraging the program effectively.

Footnotes:

[1] FDA Guidance: Breakthrough Devices Program (Sept 2023): https://www.fda.gov/media/162413/download