On June 16, the FDA released its final guidance for industry and FDA staff on Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.
The guidance document clarifies that, in general, manufacturers preparing premarket submissions for radiological 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 functions
The FDA recommends that the following information be include in a premarket submission:
1. Function description, including a technical description of the quantitative imaging function(s) included in your device at a level of detail sufficient for the agency to understand the functionality (e.g., information about input data, image acceptance activities, information presented to the user about the derived values and the level of user interaction needed for your device to be used as intended.)
2. Technical performance assessment, including performance specifications for your quantitative imagingfunction(s) that correspond to the claims and uncertainty associated with the quantitative imagingfunction described in the device labeling.
3. Labeling. Your premarket submission must include labeling in sufficient detail to satisfy any applicable requirements for your type of premarket submission. Device labeling must satisfy all applicable FDA labeling requirements and the device labeling should include sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging function.