The FDA wants manufacturers to include additional information in premarket submissions for medical devices that include quantitative imaging functions, according to a new draft guidance from the federal agency.
In the document, “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions,” the FDA asked that the added information better describe device functions, provide performance specifications for safety and effectiveness and include “enhanced product labeling to users.”
“This guidance document is applicable to all devices that generate quantitative imaging values across a wide range of imaging modalities, intended uses, levels of automation, and complexity of algorithms,” the document read. “This guidance document provides FDA’s recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for devices that include quantitative imaging functions.”
Public comments are encouraged and due by June 18.
“The utility of any quantitative imaging value is greatest if the performance of the quantitative imaging function is well characterized and users have sufficient information to understand and interpret the quantitative values being reported," according to the draft guidance. “Quantitative imaging functions have a broad range of intended uses, making it difficult to define universal criteria for achieving a ‘well-characterized’ quantitative imaging function and ‘sufficient user information,’ but we believe a general approach for developing appropriate technical performance information can be defined.”