If your device is intended for the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; and there is currently an unmet need for your device; and your device represents breakthrough technology or provides a clinical advantage (or public health need for IVD medical devices), you may qualify for Priority Review designation, which will allow your application 'front-of-queue' priority status.
Key information
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GuidanceGuidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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FormsInformation and links to the medical devices priority applicant determination application form.
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PageMedical devices priority applicant determination notices and eligibility for priority review pathway.