Breakthrough Device Designation

The FDA Breakthrough Device Program is a voluntary initiative focusing on specific medical devices and device-led combination products.

Purpose: It aims to enhance treatment and diagnosis for life-threatening or debilitating conditions, ensuring timely access to innovative medical devices.

Key Features:

• Expedited Processes:
  • Streamlines development, assessment, and review processes for various types of marketing authorizations.
• Stringent Criteria:
  • Devices must meet strict safety and effectiveness standards before authorization.
• Replaced Pathways:
  • Replaces previous pathways like the Expedited Access Pathway and Priority Review.

Criteria for Breakthrough Device Designation

Eligibility Criteria: Devices eligible for premarket approval, premarket notification, or De Novo classification can qualify if they meet certain conditions:

• Effective Treatment:
  • Offers improved treatment or diagnosis for critical conditions.
• Additional Criteria:
  • Represents breakthrough technology, lacks approved alternatives, offers significant advantages, or is deemed in patients’ best interest.

Benefits of the Breakthrough Device Program

Priority Review: Qualified devices undergo expedited review, accelerating regulatory processes.

Interactive Communication: Facilitates timely discussions and issue resolutions with the FDA, ensuring alignment with regulatory requirements.

Efficient Clinical Study Design: Offers flexible options for data collection while maintaining scientific rigor.

Dedicated Support: Provides tailored guidance and assistance from FDA review teams, enhancing the review process.

Senior Management Engagement: Promotes collaboration between FDA and sponsoring organizations, expediting decision-making.

Requesting Breakthrough Device Designation

Timing: Sponsors can request designation before submitting marketing applications.

Procedure:

1. Prepare a “Designation Request for Breakthrough Device” Q-Submission.
2. Consider the impact on other pending requests.
3. Follow detailed procedures outlined in the guidance document.
4. Submit electronically through the CDRH Customer Collaboration Portal.

Breakthrough Device Designation Statistics

As of December 31, 2023:

• A total of 933 Breakthrough Device designations granted.
• CDRH granted 921 designations, while CBER granted 12.
• Includes devices initially designated under the Expedited Access Pathway program.