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Application for priority review designation - medical devices
To apply for priority review designation for your medical device(s), you must complete and provide this application form along with sufficient supporting information which addresses the relevant eligibility criteria.
Before submitting your application, please refer to the Priority review designation medical devices (including IVDs) guidance for medical devices. This guidance outlines the application process, the criteria your device must meet to be eligible for designation, and how to pay your application fee.
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.