On October 21st, the US Food and Drug Administration (FDA) released draft guidance. Once this guidance is finalized, it will update the FDA’s 2018 guidance on the Breakthrough Devices Program (the “Program”). In its draft guidance, the FDA announced that when considering the eligibility of medical devices for the program, it will also consider whether the devices can help address medical disparities and promote health equity. In other words, in determining eligibility for Breakthrough Status, FDA specifically considers whether a device can provide more effective treatment or diagnosis in populations affected by health and/or health care disparities. I will consider it.
The Breakthrough Devices Program aims to provide patients and healthcare professionals with faster and easier access to medical devices that effectively diagnose and treat life-threatening or irreversibly debilitating diseases and conditions. Started in 2018. This program enables the FDA to speed up product development, evaluation, and review while maintaining statutory standards for premarket approval, 510(k) clearance, and De Novo marketing approval. If this latest draft guidance goes through a public comment period and is finalized, the agency plans to incorporate the proposed language into his 2018 guidance.
To address health disparities, FDA is proposing to add a new section III.B.3.d to the 2018 guidance. This section recognizes the urgent public health need for innovative technologies that help reduce barriers to achieving health equity and improve health outcomes across a range of sectors. population. . The new section is called[a]Addressing disparities in health and healthcare is not only critical to achieving health equity, but also to improving overall quality of life and health outcomes for all patients. Thus, a device “designed to address pathophysiological or clinical features relevant to a particular population that may have a clinically meaningful impact on the treatment or diagnosis of a condition in that particular population.” It proposes to consider whether In that case, the device may be “deemed to reasonably be expected to provide a more effective treatment or diagnosis” and may be eligible for Breakthrough status. The FDA states that the proposed changes “enhance the availability of certain devices that meet statutory designated standards and benefit people affected by health and/or health care disparities, thereby promoting health equity.” It has the potential to promote and promote.”
In addition to health care disparity considerations, FDA proposed the following changes to the 2018 guidance:
- in the prologuecertain nonaddictive medicine products that treat pain and addiction may not be eligible for the Breakthrough Devices Program.
- Section III.B.1 Designation Considerations FDA will add language that it will consider all information about a proposed device that could reasonably be expected to provide a more effective treatment or diagnosis.”
- The last section to receive updates is Section III.C Designation Review Process It explains when FDA may publish a designation request that was “previously published or approved by the sponsor of a Breakthrough Device Designation Request” and publishes the Breakthrough Device designation status for its intended use.
FDA is accepting comments on the draft guidance until December 18, 2022.