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  • Writer's pictureDalia Givony

FDA Breakthrough Devices Program


FDA's Breakthrough Devices Program


Does your medical device provide for more effective treatment or diagnosis for life-threatening or debilitating diseases? If so, FDA Breakthrough Devices Program might be what you need. This article covers the program's criteria, benefits, and application process for those with novel technologies.


The Breakthrough Devices Program was established by FDA in 2015 with a goal to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review process.


To be eligible for the program devices must meet specific criteria:

  1. The device has to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

  2. The device must meet at least one of the following four criteria:

· Represents Breakthrough Technology

· No Approved or Cleared Alternatives Exist

· Offers Significant Advantages over Existing Approved or Cleared Alternatives

· Device Availability is in the Best Interest of Patients


Potential benefits:

According to FDA guidelines a company with a device that was found eligible for Breakthrough Devices Program could benefit from:

· Interactive and timely communication with FDA

· Pre/Post market balance of data collection- FDA may consider the amount and nature of data that may be collected in the postmarket setting, rather than premarket, and the extent of uncertainty that may be appropriate in the benefit-risk profile at the time of approval.

· Efficient and flexible clinical study design- FDA intends to take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate.

· Review team support – additional staff with subject matter expertise to review specific aspects of the submission; for example, by providing consultation on the disease or condition at issue or on a clinical study design.

· Senior management engagement

· Priority review - All submissions for device designated as Breakthrough Device will receive priority review and receive additional review resources, as needed.

· Preapproval Inspection for PMA submission - FDA intends to expedite the review of manufacturing and quality system compliance for devices in the Breakthrough Devices Program.


How to apply for the program:

A request for Breakthrough Device designation should be submitted as a “Designation Request for Breakthrough Device” Q-Submission, at any time prior to submitting premarket approval application (PMA), premarket notification (510(k) or De Novo classification request.

In order to benefit from the program, it is recommended to submit a request at an early stage, when feasibility clinical data can be presented.

Companies can expect to receive FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving the request.



Do you think your device could be eligible for Breakthrough Devices Program?



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