The FDA has issued a final order that reclassifies certain medical imaging analyzers from Class III devices, which require premarket approvals, to Class II devices, which require only a premarket notification 510(k)—a decision that is intended to reduce the regulatory burden on manufacturers. The order is effective as of February 21.
The guidance document applies to computer-assisted detection (CADe) devices, which the FDA defines as “computerized systems that incorporate pattern recognition and data analysis capabilities … 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 intended user (i.e., a physician or other healthcare professional).” These analyzers include those applied to “mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection.”
The FDA guidance document, published on January 22, states that the final order affects CADe devices classified under 21 CFR 892.2050 “Picture archiving and communications systems” and 21 CFR 892.2070 “Medical image analyzer.” Product codes included are: New, colon computed tomography system, computer-aided detection; OEB, lung computed tomography system, computer-aided detection; and MYN, medical image analyzer. The FDA states that it intends to create new product codes to identify and track new types of CADe products as necessary.
Nonbinding recommendations from the FDA are available in the guidance document Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in – Premarket Notification (510(k)).