The final guidance for the Breakthrough Devices Program was issued by the FDA in December 2018. Under this program (part of the changes to the FD&C Act created by passage of the 21stCentury Cures Act), sponsors of devices or device-led combination products that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions” may be nominated for the program which helps improve patient access to these products through processes which expedite development, assessment and review.
The guidance describes the principles of the program, how sponsors may apply for breakthrough designation, and the features of the program that will assist sponsors with development, assessment and review for expedited clearance/approval. Devices and device-led combination products subject to review under a pre-market approval, pre-market notification, or De Novo request all have the potential for designation as a Breakthrough Device. Once device has received Breakthrough designation, there are several program modes available for additional interaction with reviewers on the product’s development and review. These modes are all managed using an “Interaction for Designated Breakthrough Device” Q-Sub. More traditional Pre-Sub topics may also be used, with the “Interaction for Designated Breakthrough Device” Q-Sub ensuring the Pre-Sub receives the expedited review under the program. The guidance ends with examples of a designation request and a data development plan.
Consistent with other CDRH/CBER programs, the Breakthrough Device Program has a web page with further information. A webinar on the program held on 17JAN2019 clarified some of the features and included a Q&A session. Readers may view the webinar slides and transcript here.
Text Copyright © 2019 Katrina Rogers