FDA’s final breakthrough devices guidance now includes technologies that address health disparities

Final guidance on the US Food and Drug Administration breakthrough device program includes new language noting that the program now can be used to benefit populations impacted by health care disparities.

The update, issued 14 September, also adds a new text aimed at deciding whether a device provides a “more effective” treatment than others, and expands its criteria for breakthrough devices to include non-addictive products to treat pain or addiction.

This new text will supersede FDA’s final guidance on breakthrough devices issued in December 2018. (RELATED: FDA Finalizes Breakthrough Device Guidance, Outlines Safer Technologies Program, Regulatory Focus 18 December 2018).

FDA adopted most of the changes that were proposed in a draft guidance issued last October (RELATED: FDA proposes breakthrough status for devices that address health disparities, Regulatory Focus 21 October 2022).

“This final guidance is intended to help the FDA and our customers leverage the interactive nature of the Breakthrough Devices Program to further advance health equity,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), said in a statement.

The breakthrough device program, formerly known as the Expedited Access Pathway, was created by the 21st Century Cures Act.

In a section on designation considerations, the update adds new criteria for deciding whether a device provides a “more effective” treatment or diagnosis.

“FDA considers the totality of information regarding the proposed device, its function, potential for technical success, potential for clinical success, potential for a clinically meaningful impact, and its potential benefits and risks. The determination of whether a device is reasonably expected to ‘provide for more effective treatment or diagnosis’ is based upon all these factors,” according to the guidance.

It also adds a category of devices eligible for breakthrough status to include those that reduce disparities.

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

It also includes a new confidentiality clause stating the agency will not disclose breakthrough therapy requests and decisions made on these requests.

FDA also proposed that non-addictive medical products for treating pain or addiction be considered eligible for breakthrough designation.

Since the launch of the breakthrough program in 2018, the agency has granted breakthrough status to 839 devices, including devices originally designated under the Expedited Access Pathway (EAP) program. Of the 839 devices granted Breakthrough Device designation, CDRH has granted 831 and CBER has granted eight.

Final guidance, Notice

FDA’s final breakthrough devices guidance now includes technologies that address health disparities

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