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GUIDANCE DOCUMENT

Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance for Industry and Food and Drug Administration Staff June 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-1470
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1470.

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