The FDA has released the final versions of guidelines for the premarket notification and approval of computer-assisted detection technology applied to radiology images and radiology device data.
Released in two separate documents, the guidelines are updates to drafts published in the Federal Register in October 2009. They apply only to computer-assisted detection (CADe) technology, which the FDA differentiates from computer-assisted diagnosis (CADx) technology. CADx was not covered in the guidelines.
The FDA defines CADe as devices which are “computerized systems intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the clinician.” It specifies CADe can be a unique detection scheme or set of schemes designed to detect one type of potential abnormality, such as colonic polyps on CT colonography studies or lung nodules on MRI studies.
CADx devices, on the other hand, include technology intended to provide an assessment of disease, predict the likelihood of the presence of disease, specify disease type or recommended intervention strategies.
The first document, which provides information on documentation and performance testing for 510(k) submissions, can be found here.
The second guidance document, which covers both 510(k) and premarket approval applications, can be found here.