FDA proposes to update Breakthrough Device guidance

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated ‘breakthrough products’. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.
These updates were proposed in a recent draft guidance. If adopted, the measures would be incorporated into FDA’s final guidance on breakthrough devices issued in December 2018.

The update also adds a new “totality of information” test in deciding whether a device provides a “more effective” treatment or diagnosis in the section on designation requests. “When evaluating this part … FDA 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.”

Lastly, a new confidentiality clause has been proposed stating the agency will not disclose breakthrough therapy requests and decisions made on these requests. In certain cases, however, FDA may publicly disclose these requests if they have been previously disclosed or acknowledged by sponsors.

The deadline for commenting is 20 December 2022.