FDA Breakthrough Device Program and Progress

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To protect and promote public health, the FDA has established a voluntary Breakthrough Device Program for certain medical devices and device-led combination products used to treat/diagnose life-threatening or irreversibly debilitating diseases. In this article, we provide an overview of the Breakthrough Device Program and its latest developments.

Introduction of the Breakthrough Devices Program

The Breakthrough Devices Program is designed to provide timely access to medical devices for patients and healthcare providers by expediting the development, evaluation, and review processes for Premarket Approval (PMA), Premarket Notification (510(k)), and De Novo Marketing Authorization.

Breakthrough devices must meet the FDA's stringent device safety and effectiveness criteria for receiving marketing authorization. The Breakthrough Device Program replaces the Rapid Access Pathway and Priority Review for medical devices, and FDA considers devices designated under the Rapid Access Pathway to be part of the Breakthrough Device Program.

According to the official FDA release, as of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and marketing authorization to 77 devices with Breakthrough Device designation. These devices represent a wide range of intended uses and cross regulatory pathways, underscoring the impact of the program.

Advantages of Joining the Breakthrough Device Program

Timely and Effective Communication with FDA

The Breakthrough Device Program provides device manufacturers with a variety of ways to interact with FDA experts to effectively address issues that arise during the pre-market review phase of a device. Manufacturers can receive timely feedback from the FDA through interaction and identify areas of agreement.

Manufacturers may be prioritized in the review process involved

How to Qualify for the Application?

For devices subject to a PMA, 510(k), or De Novo, they are eligible for breakthrough device designation if they meet the following two criteria:

The first criteria

The device more effectively treats or diagnoses a life-threatening or irreversibly debilitating human disease or condition.

The second criteria

The device also meets at least one of the following criteria:

Represents breakthrough technology
No approved or cleared alternative exists
Offers significant advantages over existing approved counterparts or alternatives
Device availability is in the best interest of the patient

How to Apply for the Breakthrough Device Program?

Device manufacturers can request Breakthrough Device Designation by submitting a "Breakthrough Device Designation Request" Q-Submission at any time prior to the submission of a marketing application. And your designation request should be the only request in the Q-Submission.

If you are seeking a breakthrough device designation and have other feedback requests pending, it is recommended that you send your feedback request after FDA has made a designation decision, as the designation may affect FDA's feedback on your other requests.

The process for submitting a Q submission is outlined in the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

Elements of a Breakthrough Device Designation Request

The FDA officially publishes what is recommended to be included in a breakthrough device request:

Information describing the device
Instructions for the use of the device (indications)
Historical regulatory status
Reasons for the product meet the statutory criteria for a breakthrough device
Your planned pathway for filing your device with FDA

Notification of the Application Result

FDA informs the applicant of the breakthrough device designation decision by making a request for additional materials within 30 days of receiving the breakthrough device program application.

FDA will notify you by letter within 60 days of receipt of your request whether your product has received Breakthrough Device Program designation.

Breakthrough Device Program Final Guidance

On September 14, 2023, the FDA updated the Breakthrough Device Program Final Guidance.

FDA issued updated final guidance on the Breakthrough Device Program based on draft guidance issued on October 20, 2022: Reducing Disparities in Health and Health Care. Highlights of the final guidance:

Clarifying how the Breakthrough Device Program applies to certain innovative medical devices that may address health disparities.
Clarifying that the Breakthrough Device Program may apply to certain non-addictive medical products to treat pain or addiction.
Providing filers with a reference to resources on the assessment and reporting of various health equity data points in medical device clinical studies.
Clarifying FDA's current interpretation of the breakthrough device designation criteria. The final guidance states that FDA's interpretation of "more effective" is based on the totality of available information about the device, including the device's potential to have a clinically meaningful impact and its risks and benefits compared to the standard of care.
FDA may consider improving the accessibility of a device when evaluating whether the device meets the first breakthrough criteria.
Describing how to disclose the breakthrough status of a designated device when it receives marketing authorization.
Clarifying considerations in designing equipment, including qualified equipment that may support new and existing technological innovations to address inequities.
Reflecting CDRH's commitment to providing patients and healthcare providers with timely access to high-quality, safe, and effective medical devices of public health importance.

If you hope to apply for the FDA Breakthrough Device Program for your medical device, please contact us.