On October 21, the U.S. Food and Drug Administration (FDA) released draft guidance that, if finalized, will update the agency’s 2018 guidance on its breakthrough device program (the “ program “). In the draft guidelines, the FDA announced that when considering medical devices for eligibility for the program, the agency will also consider whether a device will help reduce health care disparities and promote the health equity. In other words, the FDA intends to specifically consider whether a device can provide more effective treatment or diagnosis in populations affected by health and/or health care disparities when determining eligibility for revolutionary status.
The Breakthrough Devices program was launched in 2018 to provide patients and healthcare workers with faster and easier access to medical devices that effectively diagnose and treat life-threatening or irreversibly debilitating diseases or conditions. This program allows the FDA to expedite the development, evaluation, and review of products while preserving legal standards of premarket approval, 510(k) clearance, and marketing authorization. De Novo market. If this latest draft guidance is finalized after a public comment period, the agency will incorporate the proposed language into the 2018 guidance.
To address health disparities, the FDA is proposing to add a new Section III.B.3.d to the 2018 guidance in which it recognizes the urgent public health need for innovative technologies that help reduce barriers to health. health equity and improve health outcomes in various areas. populations. . The new section would recognize that “[a]addressing health and health care disparities is not only important for achieving health equity, but also for improving overall quality of life and health outcomes for all patients. It thus proposes to take into account whether a device “is designed to treat a physiopathological or clinical characteristic associated with certain populations which could have a clinically significant impact for the treatment or diagnosis of the disease in these populations”. If so, the device may “be considered reasonably likely to provide more effective treatment or diagnosis” and therefore may be eligible for breakthrough status. The FDA says the proposed changes “could accelerate the availability of certain devices that meet statutory designation criteria and benefit populations affected by health and/or health care disparities, thereby promoting and advancing equity.” health matter”.
In addition to health care disparities considerations, the FDA has proposed the following other changes to the 2018 guidelines:
- In the Introductioncertain non-addictive medical products intended to treat pain or addiction may not be eligible for the Breakthrough Devices program.
- Section III.B.1 Designation Considerations will have added language stating that the FDA “will consider all information about a proposed device, including its function, potential for technical success, potential for clinical success, potential for clinically significant impact, and potential benefits and risks when of the evaluation whether a device is reasonably expected to provide more effective treatment or diagnosis”
- The last section receiving updates is Section III.C Designation Review Process which will describe when the FDA may publicly disclose Designation Applications that have been “previously publicly disclosed or acknowledged by the sponsor of the Breakthrough Device Designation Application” and will publicly disclose its Breakthrough Device Designation status for its intended use.
The FDA will accept comments on the draft guidance until December 18, 2022.