Breakthrough Devices Program

Non-binding Guidance

The sixth installment of Ropes & Gray’s podcast series, Non-binding Guidance, continues our two-part discussion on FDA expedited review programs. In this episode, Ropes & Gray lawyer Kellie Combs interviews her partner Greg Levine, who provides an overview of FDA’s new Breakthrough Devices Program. This program, which was finalized in late 2018, aims to expedite the development and FDA premarket review of devices used in the treatment or diagnosis of serious or life-threatening conditions. The Breakthrough Devices Program provides a variety of benefits to manufacturers, including priority review and more frequent and efficient feedback from FDA during the submission and review process, so that devices receiving breakthrough designation can reach the patients who need them quickly and efficiently. In this episode, Greg dives into the program’s eligibility criteria, benefits, when to apply, and some of the practical considerations associated with the program. Additionally, Kellie and Greg discuss recent trends and developments affecting breakthrough devices and provide examples of devices that have recently received breakthrough device designation or that were approved or cleared as breakthrough devices. Tune in to this discussion to learn more about the program and its impact on the medical device industry.