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Medical Devices / Regulatory Affairs

FDA Releases Final Guidance on Breakthrough Devices Program

Dec. 26, 2018

The FDA has put out a final guidance on its breakthrough devices program that frames the program’s policies, features and pathway manufacturers should follow when pursuing the breakthrough designation.

The program was designed to give breakthrough device developers a faster way to obtain agency feedback on their devices, as assessments on breakthrough devices can take time due to their complexity.

The final guidance includes outlines on several program features designed to enable efficient device development, such as sprint discussions, which are meant to be held between FDA and sponsors who require fast resolutions of certain issues.

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