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Breakthrough designation check

Breakthrough designation brings prioritised review and more contact with FDA, not a lower bar. It has two statutory criteria. Answer the questions to see how your device measures up.

Does the device treat or diagnose a life-threatening or irreversibly debilitating disease or condition?

Yes No

Would it give more effective treatment or diagnosis than what exists?

FDA looks for a reasonable expectation, usually supported by early data.

Yes No Not sure

Which of these apply? (at least one is needed)

It represents breakthrough technology No approved or cleared alternative exists It offers significant advantages over existing alternatives Its availability is in the best interest of patients

See the answer

A screening aid, not a determination. The answer follows FDA's published guidance and cites it, but only FDA decides, through a Pre-Sub, a 513(g) or the submission itself. Confirm with FDA or a qualified regulatory professional. Fees and review goals are planning figures. Nothing you answer is saved.

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The Breakthrough Devices Program in plain terms.

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