The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program offers manufacturers special opportunities to interact with FDA experts during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers of devices selected for the program can also expect prioritized review of their submission. As of September 30, 2022, FDA had granted 728 Breakthrough Device designations.

In October 2017, FDA published the draft guidance “Breakthrough Devices Program,” finalized in December 2018, which laid out the policies by which FDA intended to implement the program. On October 21, 2022, FDA proposed new draft guidance that would add clarification to the December 2018 final guidance on how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity and the standard of evidence that FDA will require to support designation.

When weighing eligibility for the Breakthrough Devices Program, FDA is proposing a clarification regarding how to support meeting the “more effective” element of the standard, noting that it will consider the totality of available information regarding the device, including its potential for a clinically meaningful impact and its potential benefits and risks (emphasis added). According to the new draft guidance, when determining which medical devices are eligible for the Breakthrough Devices Program, FDA intends to consider “technologies and device features that may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 agency acknowledges the “urgent public health need for innovative technologies that help to reduce barriers to achieving health equity and help to improve health outcomes across diverse populations.”

Thus, FDA will be more likely to grant breakthrough device designation to “device features tailored to address characteristic differences, such as those arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment, when evaluating if there is a reasonable expectation that the device may provide for more effective treatment or diagnosis as compared to the current standard of care, including the device’s potential to be more effective in certain populations,” the draft guidance says. In addition, breakthrough device designation is more likely to be granted to new devices that have the potential to offer a clinically meaningful impact through improved accessibility; for example, FDA may favor program eligibility for a medical device that includes user features that are adaptable or more easily used by diverse populations or allow for use in more diverse settings.

The draft guidance also specifies that certain non-addictive medical products to treat pain or addiction may be eligible for the Breakthrough Devices Program. Last, the new guidance adds clarification on when FDA may disclose information regarding submitted breakthrough device designation , noting that the agency generally will not disclose the existence of requests for Breakthrough Device designation and the associated decisions on such requests until the device receives marketing authorization.

Authored by Randy Prebula, Lina Kontos, and Blake Wilson