Breakthrough Device Designation: I’ve Received the Designation, Now What?

Apr 3, 2023 | White Paper |

Breakthrough Device Designation: I've Received the Designation, Now What?Being in unchartered territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high degree of support for these devices. The program provides an opportunity to receive significant FDA feedback in the early stages of the development process, and throughout the development process. This FDA involvement is especially valuable for startups with a new novel device or technology.

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