Medical Device Breakthrough Designation

Medical Device Breakthrough Designation

Oct 20, 2020
By Becky Ditty, Consultant


With Centers for Medicare and Medicaid Services (CMS) now offering an add-on payment  route for breakthrough designated medical devices, it is anticipated that more companies will be submitting requests to FDA for breakthrough designation status.

To qualify for breakthrough designation as defined in section 515B(b) of the FD&C Act (21 U.S.C. 360e-2(b)), the device must meet Criterion 1 (described below) as well as one of the criteria described in Criterion 2.

Criterion 1:

Devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and

Criterion 2:

(A) that represent breakthrough technologies

(B) for which no approved or cleared alternatives exist;

(C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patient’s ability to manage their own are (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or

(D) the availability of which is in the best interest of patients.

Additionally, the designation must be granted prior to submitting a marketing application for the device.

A Designation Request for Breakthrough Devices Q-Submission should include:

  • a detailed device description, including: principles of operation, properties relevant to clinical function, and images or engineering drawings
  • indications for use statement
  • details regarding prior FDA communications and submission for the device
  • a discussion regarding how the program requirements are met by the proposed device
  • planned marketing application (PMA De Novo request, 510(k)), including rational for application type

The main benefit for being designated a breakthrough device is access to the sprint process, which is intended to be highly interactive between FDA and the sponsor.

For additional details, including timelines associated with a breakthrough device designation and when a device would benefit from the designation, refer to our in-depth article and to FDA guidance “Breakthrough Devices Program”.


Food and Drug Administration (FDA). (2020). Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff. Retrieved from source.


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