The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or addiction

In addition, the guidance clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria. In particular, the update explains that the FDA’s interpretation of “more effective” is based upon the totality of available information about the device, including the potential for the device to make a clinically meaningful impact and the risks and benefits compared to standard of care. The final guidance also explains that the FDA may consider improved accessibility of a device when evaluating if it could meet the first breakthrough criterion.

The FDA will host a webinar on Tuesday, November 14, 2023, at 1pm ET for those interested in learning more about the updated final guidance.

Designation Criteria

To meet the criteria for Breakthrough Device designation, the medical device must:

1. Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and
2. Represent breakthrough technologies;
   • for which no approved or cleared alternatives exist;
   • 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 patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
   • the availability of which is in the best interest of patients.

Device must meet the first criteria and at least one of the sub-criteria under section 2.

Addressing Healthcare Disparities

When assessing eligibility for the Breakthrough Devices Program using the designation criteria, FDA intends to consider technologies and device features that may help to address health and/or healthcare disparities and promote health equity by providing for more effective treatment or diagnosis in populations that exhibit health and healthcare disparities.

This may include technologies and device features tailored to address characteristic differences arising from social factors, phenotypic variations, pathophysiology and/or response to treatment. When evaluating if there is a reasonable expectation that the device may provide for more effective treatment or diagnosis as compared to the current standard of care, the FDA will also consider the device’s potential to be more effective in certain populations or for the treatment of life-threatening or irreversibly debilitating diseases or conditions that are rare, such as sickle cell disease.

Improved Access to Care

When evaluating the first Breakthrough criterion, FDA intends to consider technologies and device features that could allow for improved accessibility when evaluating whether the device may provide for more effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population with limited or no available options may have improved adherence to a prescribed medical regimen.

As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation.