The US Food and Drug Administration (FDA) has issued a draft guidance document on premarket submissions for devices with quantitative imaging functions, titled ‘Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions’, copy available from here.
FDA explains that most medical images require a trained physician to identify the presence or absence of a certain 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 sufficient user information.
FDA recommends in the guidance that 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”
Comments are invited on the draft by 18 June 2019.