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Breakthrough Devices Program

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What is the Breakthrough Devices Program?

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

What are the benefits of the Breakthrough Devices Program?

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.

Is my device eligible?

Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo designation are eligible for breakthrough device designation if both of the following criteria are met:

Criteria Description Refer to Guidance
First Criterion The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions Section III.B.1
Second Criterion The device also meets at least one of the following:  
  1. Represents Breakthrough Technology
Section III.B.2.a
  1. No Approved or Cleared Alternatives Exist
Section III.B.2.b
  1. Offers Significant Advantages over Existing Approved or Cleared Alternatives
Section III.B.2.c
  1. Device Availability is in the Best Interest of Patients
Section III.B.2.d

When to request a Breakthrough Devices Designation

You can send a Breakthrough Designation request for your device at any time prior to sending your marketing submission (for example, premarket approval (PMA), premarket notification (510(k)), or De Novo classification request).

How to request a Breakthrough Devices Designation

You can request the Breakthrough Device designation by submitting a "Designation Request for Breakthrough Device" Q-Submission. Your designation request should be the only request in the Q-Submission. If you are pursuing the Breakthrough Device designation while you have other requests for feedback pending, you may want to send the requests for feedback after the FDA makes a designation decision because the designation may affect the feedback that the FDA provides on your other requests. The procedures for submitting a Q-Submission are outlined in the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

The FDA may find devices that could be good candidates for the Breakthrough Devices Program and recommend that sponsors of such devices consider applying to the program.

What to include in a request for a Breakthrough Devices Designation

The FDA recommends that your designation request include information to describe the device, the proposed indication for use, regulatory history, how your device meets the statutory criteria for a Breakthrough Device, and what type of marketing submission you plan to submit to the FDA for your device. Learn more about what to include in your request in Appendix 1 of the Breakthrough Devices Program final guidance.

When will I find out if my device received Breakthrough Device Designation

The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request.

It is helpful when a sponsor is available and responsive to the FDA's requests throughout the review timeline. If the FDA does not receive the other information needed to decide on a designation request promptly, it may result in denial of the Breakthrough Device designation request.

What a sponsor can expect from FDA if Breakthrough Designation is Granted

If your device is granted the Breakthrough Device Designation, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including sprint discussions, request for discussion on a data development plan, and request for clinical protocol agreement. Learn more about these options in Section IV of the Breakthrough Devices Program guidance.

You will also receive prioritized review on future regulatory submissions, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.

Are there related programs designed to expedite the availability of certain devices that might apply to my device?

If your device is not eligible for a Breakthrough Device Designation because it is not intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, you may consider whether or not it would be a candidate for the Safer Technologies Program.

Guidances related to Breakthrough Devices

Contact Us

For any questions about the Breakthrough Devices program, please contact [email protected].


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