FDA releases updated final guidance for its Breakthrough Devices Program


On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities. 

The final guidance defines the FDA’s interpretation of “more effective” as encompassing all the information about the device, including the risks and benefits of using the device compared to the standard of care, as well as its potential to make a clinically meaningful impact. 

It also explains that the program may be available for certain nonaddictive medical products to treat addiction or pain. 

The guidance states the FDA may consider improved accessibility of a device while determining if it meets the first breakthrough standard. It depicts how the FDA determines the Breakthrough status of designated devices after it receives marketing authorization. 

The Breakthrough Devices Program seeks to identify and provide patients and healthcare professionals with timely access to devices that can provide more effective treatment or diagnosis of irreversibly debilitating or life-threatening conditions. 

The Agency said that as of June 30, it has granted marketing authorization to 77 of the 831 devices that have received Breakthrough Device Designation. 

The updated final guidance follows the draft guidance issued in late 2022, aimed at reducing disparities in health and healthcare. 

The FDA also highlighted its TAP Pilot program, intended to “de-risk the medical device valley of death” by allowing for earlier interactions between industry, the FDA and key stakeholders. The voluntary program is designed to help improve different aspects of device development and speed up the time to commercialization.

“By facilitating coordination of earlier, solutions-oriented input from patients, health care providers, and payers, the TAP Pilot can help developers better address patient needs and anticipate coding, coverage, reimbursement, and market adoption considerations. That input can be of significant value throughout device design and development, during clinical trials, and even when rolling out devices post-authorization,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. 

As a next step, the FDA will host a webinar for interested parties to learn more about the updated final guidance on Nov. 14 at 1 p.m. ET. 


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