Three years after the draft guidance was published, the U.S. Food and Drug Administration (FDA) has published its final guidance for manufacturers planning to submit radiological devices with quantitative imaging functionality for premarket review.
The guidance document applies to regulatory submission for all devices that generate quantitative imaging values, encompassing a wide range of radiological imaging modalities, intended uses, levels of automation, and complexity of algorithms, according to the FDA. Specifically, the document delineates the function description, technical performance assessment, and user instructions that should be included in premarket submissions.
"The rigor of the technical performance assessment and the breadth/specificity of the information provided to the user in the labeling should ensure that the intended use of the device is adequately supported and considers the benefit-risk profile of the information provided by the quantitative imaging function," the FDA wrote.
The FDA's draft guidance for technical performance assessment of quantitative imaging was initially published in April 2019.
Even with rigorous assessment of technical performance, clinical validation may also be necessary, though, depending on the device's intended use. The FDA noted that the document isn't intended to provide guidance on the types of scientific evidence needed to assess the technical performance for specific intended uses of the device. Furthermore, clinical validation of any quantitative imaging values is also outside the scope of this guidance document, according to the FDA.
"For example, a function that reports a percent stenosis value from the ratio of two vessel diameters would be considered a quantitative imaging function and the technical performance assessment of that quantitative imaging function would be within the scope of this document," the FDA wrote. "However, linking the probability of a cardiac event to the percentage of vessel stenosis would be outside the scope of this guidance document."
The final guidance document is available on the FDA's website.