Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions

16 June 2022 — FDA published the final guidance for industry and FDA staff.

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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