FDA Finalizes Breakthrough Devices Program


Posted December 21, 2018

The Food and Drug Administration (FDA) has issued final guidance that details the policies, features, and application process for the agency’s new Breakthrough Devices Program. The program was established by the 21st Century Cures Act to provide developers with “a more agile process” to get feedback from the FDA during the premarket clearance process, paving the way for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition[s].”

Sponsors of devices obtaining breakthrough status will receive “interactive and timely communication” with assigned FDA staff who are experienced in “innovative approaches to regulatory science” as well as clear communication of the FDA’s expectations. Breakthrough devices, which includes those granted designation under the FDA’s Expediated Access Pathway, will also be placed at the top of the review queue; however, review times for these devices might still be longer than for other devices because of the “novel scientific issues these devices may raise,” the FDA wrote.

“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.

Devices that receive a breakthrough designation will still need to meet the premarket approval standard of safety and effectiveness, according to the guidance document. The FDA will consider the amount of postmarket versus premarket data collection, along with the extent of uncertainty, when making its benefit-risk determination.

“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 (e.g., a device that treats a life-threatening disease when no alternative treatments are available) and adequate postmarket controls to support premarket approval,” the FDA 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 inspection would take place within a year of approval, according to the FDA.

The finalization of the Breakthrough Devices Program furthers this year’s efforts by the FDA to streamline access to new medical devices through proposed updates to its 510(k) premarket clearance process and De Novo classification pathway, as outlined in its Medical Device Safety Action Plan. In addition, the FDA has announced plans to establish a program intended to help devices that do not meet breakthrough device criteria but “through innovative designs, have the potential to be significantly safer than currently available alternative treatments or diagnostics,” Shuren said. Details on that program, called the Safer Technologies Program, are expected to be released in 2019.

The FDA is accepting public comments on the final guidance document at www.regulations.gov (docket number FDA-2017-D-5966). The FDA is also hosting a webinar on Jan. 17 to provide more information to manufacturers.