Dive Brief:

• The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities. 
• Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program. 
• The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy.

Dive Insight:

The FDA designed the breakthrough program to support development of devices that could better treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Originally, the guidance lacked a specific reference to accessibility as a way that devices can improve care.

In October, the FDA proposed updating the guidance to explain that it 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” when assessing if a new technology is “more effective.”

The FDA made its focus on health equity more explicit by proposing a new guidance section on reducing disparities in health and healthcare. In the proposed section, the regulator said it “intends to consider technologies and device features that could allow for improved accessibility when evaluating if there is a reasonable expectation that the device may provide for more effective treatment or diagnosis.”

This week, the FDA added the proposed sections to the final guidance with only minor changes. The text on considering the “totality of information” was effectively unchanged. The FDA made small changes to the “reducing disparities” section, adding age and disability as factors that can affect treatment results and explaining that age-related physiological changes may drive differences in health outcomes.

In a statement, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the update reflects a “commitment to providing patients and health care providers with timely access to high-quality, safe and effective medical devices of public health importance” and said the changes aligned with CDRH’s strategic priority to advance health equity.