AAMI News February 2019

FDA Finalizes Breakthrough Devices Program

Breakthrough DevicesThe Food and Drug Administration (FDA) says it is willing to accept greater “uncertainty” in its benefit-risk analysis of breakthrough devices as part of a new approval program that will also involve more regular communication with device developers.

Those details were shared in a final guidance document detailing the agency’s new Breakthrough Devices Program, which is intended to create “a more agile process” for clearing devices that provide “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition[s].”

Breakthrough devices, which include those granted designation under the FDA’s Expedited Access Pathway, will receive “interactive and timely communication” with assigned FDA staff. They also will be placed at the top of the review queue; however, review times for these devices might still be longer than those for other devices, according to the FDA.

“Breakthrough device innovations that are highly novel can be challenging and more complex for the FDA to assess. We know from experience that more frequent interactions with device developers during product development can result in identifying more efficient ways of evaluating these novel devices’ benefits and risks and facilitate a timelier premarket review, which is especially important since timely patient access is critical with these types of devices,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.

Although breakthrough devices must still meet the premarket approval standard of safety and effectiveness, the FDA said it will consider the amount of postmarket versus premarket data collection when making benefit-risk determinations.

“FDA may accept a greater extent of uncertainty of the benefit-risk profile for these devices if appropriate under the circumstances, including that the uncertainty is sufficiently balanced by other factors, such as the probable benefits for patients to have earlier access to the device … and adequate postmarket controls to support premarket approval,” the agency wrote.

The agency might also accept less quality system or manufacturing information or forgo an inspection of certain manufacturing sites prior to approval of a breakthrough device if other requirements or alternative approaches are met. The delayed inspection would take place within a year of approval, according to the FDA.