Guidance Document
Guidance for Industry and Food and Drug Administration Staff
JUNE 2022
This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions.
Download the FINAL Guidance Document
FINAL
Read the Federal Register Notice
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