Assessment of Quantitative Imaging Devices Guide

Federal Register notice: FDA has made available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” The document says that manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide 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 function. The guidance applies to all devices that generate quantitative imaging values across a wide range of imaging modalities, intended uses, levels of automation, and complexity of algorithms. To view the notice, click here.