FDA proposes breakthrough status for devices that address health disparities

Regulatory NewsRegulatory News | 21 October 2022 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.
These updates were proposed in a recent draft guidance issued on Thursday. If adopted, the measures would be incorporated in 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).
The breakthrough device program, formerly known as the Expedited Access Pathway, was created by the 21st Century Cures Act.
Under the first change, the agency proposes to broaden the category of devices eligible for breakthrough status to include those that reduce disparities in health in the section on designation requests.
It states that “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.”
Devices that serve an unmet medical need, such as treatments for rare diseases or conditions are considered products that reduce health care disparities. “FDA considers technologies and device features tailored to address unmet needs in these populations when evaluating if there is a reasonable expectation that the device may provide for more effective treatment of diagnosis.”
FDA also proposed that non-addictive medical products for treating pain or addiction be considered eligible for breakthrough designation; the change would amend the introduction of the final guidance.
The update also adds a new “totality of information” test in deciding whether a device provides a “more effective” treatment or diagnosis in the section on designation requests. “When evaluating this part … 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.”
Lastly, a new confidentiality clause has been proposed stating the agency will not disclose breakthrough therapy requests and decisions made on these requests. In certain cases, however, FDA may publicly disclose these requests if they have been previously disclosed or acknowledged by sponsors.
The deadline for commenting is 20 December.
Breakthrough devices update
Final device breakthrough guidance


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