The FDA has released a new draft guidance focused on the completion of premarket submissions for medical devices with quantitative imaging functions. Submissions for such devices should include additional information, according to the FDA, due to their key role in patient care and susceptibility to “systematic errors and random variation.”
“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users have sufficient information to understand and interpret the quantitative values being reported,” according to the draft guidance.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.”
On all premarket submissions for these devices, the FDA wants information included that is related to the product’s quantitative imaging function, its intended input images, how those images are accepted, what details it presents to the user and the amount of required user interaction.
Performance specifications for the device’s quantitative imaging function are also needed.
“In general, quantitative imaging functions should have quantitative performance specifications that correspond to the claims and uncertainty associated with the quantitative imaging function described in the device labeling,” according to the draft guidance. “The appropriate performance specifications will depend on the intended use of the quantitative imaging function, the complexity of the measurement algorithm, and the availability of reference values. Additionally, performance specifications may change throughout the operating range of the quantitative imaging function.”
In addition, all claims a vendor is making about its device’s quantitative imaging function should be supported by studies that pass the FDA’s applicable acceptance criteria.
The draft guidance also goes into detail about the necessary device labeling that must be included with all premarket submissions.
“Your device labeling should include sufficient information for the end user to obtain, understand, and interpret the values provided by the quantitative imaging function,” according to the draft guidance.
The full FDA document, “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions,” is available here. Comments are being accepted until June 18.
The American College of Radiology provided some information on the draft guidance on its website, providing instructions for any members have specific questions or concerned.