1/4/22, 4:49 PM Breakthrough Devices Program | FDA
Breakthrough Devices Program
On this page:
What is the Breakthrough Devices Program?
What are the benefits of the Breakthrough Devices Program?
Is my device eligible?
When to request a Breakthrough Devices Designation
How to request a Breakthrough Devices Designation
What to include in a request for a Breakthrough Devices Designation
When will I find out if my device received a Breakthrough Device Designation
What a sponsor can expect from the FDA if the Breakthrough Devices Designation is
granted
Are there related programs designed to expedite the availability of certain devices that
might apply to my device?
Guidances related to Breakthrough Devices Program
Contact Us
What is the Breakthrough Devices Program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and
device-led combination products (/combination-products/about-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?
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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 (/regulatory-information/search-fda-guidance-documents/breakthrough-devices-
program).
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:
Refer to
Criteria Description Guidance
First The device provides for more effective treatment or diagnosis of life-threatening or Section
Criterion irreversibly debilitating human disease or conditions III.B.1
Second The device also meets at least one of the following:
Criterion
a. Represents Breakthrough Technology Section
III.B.2.a
b. No Approved or Cleared Alternatives Exist Section
III.B.2.b
c. Offers Significant Advantages over Existing Approved or Cleared Alternatives Section
III.B.2.c
d. 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-
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Submission are outlined in the guidance Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program (/regulatory-information/search-fda-
guidance-documents/requests-feedback-and-meetings-medical-device-submissions-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 (/regulatory-
information/search-fda-guidance-documents/breakthrough-devices-program).
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 (/regulatory-information/search-fda-guidance-
documents/breakthrough-devices-program).
You will also receive prioritized review on future regulatory submissions, including Q-
Submissions, Investigational Device Exemption (IDE) applications, and marketing
submissions.
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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 (/medical-devices/how-study-and-market-your-device/safer-
technologies-program-step-medical-devices).
Guidances related to Breakthrough Devices
Breakthrough Devices Program Final Guidance (/regulatory-information/search-fda-
guidance-documents/breakthrough-devices-program)
Factors to Consider When Making Benefit-Risk Determinations in Medical Device
Premarket Approval and De Novo Classifications (/regulatory-information/search-fda-
guidance-documents/factors-consider-when-making-benefit-risk-determinations-
medical-device-premarket-approval-and-de) (Benefit Risk Final Guidance)
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in
Premarket Notifications (510(k)) with Different Technological Characteristics -
Guidance for Industry and Food and Drug Administration Staff (/regulatory-
information/search-fda-guidance-documents/benefit-risk-factors-consider-when-
determining-substantial-equivalence-premarket-notifications-510k)
Requests for Feedback and Meetings for Medical Device Submissions: The Q-
Submission Program (/regulatory-information/search-fda-guidance-
documents/requests-feedback-and-meetings-medical-device-submissions-q-
submission-program)
Contact Us
For any questions about the Breakthrough Devices program, please contact
BreakthroughDevicesProgram@fda.hhs.gov
(mailto:BreakthroughDevicesProgram@fda.hhs.gov).
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