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Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions

June 17, 2022

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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FDA North America Technical Performance Assessment Agency Alerts Center for Devices and Radiological Health Regulatory Sciences



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