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Medical Devices / Submissions and Approvals

CDRH Publishes Premarket Submission Guidance for Devices with Quantitative Imaging Features

April 25, 2019
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The FDA’s Center for Devices and Radiological Health released a draft guidance on premarket submissions for devices with quantitative imaging functions.

Most medical images require a trained physician to identify the presence or absence of a certain r feature. Quantitative imaging extracts additional information from images in the form of numerical values. Because quantitative imaging functions have a broad range of intended uses, it is often difficult to define universal criteria for achieving a well characterized quantitative imaging function and enough user information, CDRH said.

Premarket submissions should generally include “performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions,” CDRH said.

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