Medical device

FDA Breakthrough Device Update

Select Updates to the Breakthrough Devices Program

December 9, 2022
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Claudia Murillo
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In October 2022, the FDA released a draft guidance on Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care [1]. With these updates, the FDA is looking to expand the eligibility criteria for Breakthrough Devices for products that will help to reduce disparities in health and health care.


The final guidance for the Breakthrough Devices Program was issued in 2018 [2]. This program was established to support and expedite the development of devices representing “breakthrough technologies.” Section III. Designation Request of this guidance outlines the criteria that a device must meet in order to be eligible for designation as a Breakthrough Device. The device must first “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” Second, it must represent breakthrough technologies which means that either “no approved or cleared alternatives exist;” it offers “significant advantages over existing approved or cleared alternatives;” or “the availability of which is in the best interest of patients.” In order to be granted Breakthrough Device designation, the device must meet that first criterion plus one of the three subsections under the second criterion.

It is an increasingly popular program, with 728 devices granted Breakthrough Device designation since 2015, per metrics published by the FDA [3]. The program has gained pace over the years, especially since 2018 when the Breakthrough Devices Program final guidance was released. 


With the release of the Select Updates draft guidance, the agency is proposing to include new content to the original Breakthrough Devices Program guidance. This new content is meant to specifically include devices that would address and promote health equity by expanding the criteria for Breakthrough Devices. 

When finalized, these sections of the Breakthrough Devices Program guidance will be updated:

  • The Introduction section will state that certain non-addictive medical products to treat pain or addiction may be eligible for the Breakthrough Devices Program.
  • Section III.B.1 - First Criterion will include new language to elaborate that the level and type of evidence needed to meet criterion 1 may vary depending on the device. It expands the considerations for evaluating this criterion, stating that the FDA will consider the totality of information available for the proposed device. 
  • Section III.B.3 - Additional Considerations will include a new sub-section “d. Reducing Disparities in Health and Health Care”. This new section provides much more context behind the FDA’s thinking regarding health and health care disparities, dimensions that contribute to these disparities, and why it is important to encourage health equity. 
  • Section III.C Designation Review Process will add new language regarding the disclosure of Breakthrough Device designation requests. It clarifies that FDA generally does not disclose the existence of requests for designation or their decision on designation requests. This new language will also provide context behind certain cases in which this information would be disclosed.


With these proposed changes to the breakthrough devices program, the FDA is making moves to address health disparities for underserved populations. These updates provide additional regulatory support from the FDA, which demonstrates their commitment to addressing health disparities. The intent is to leverage the current framework of the breakthrough devices program to provide more timely access to devices that address the unmet needs of populations that experience health and/or health care disparities. 

The FDA will accept public comments on this draft guidance until December 20, 2022. Once final, the Breakthrough Devices Program guidance, issued on December 18, 2018, will be updated to include new language in the Introduction and Section III.