Today FDA announced that it is reclassifying certain medical image analyzers from Class III to Class II devices. These devices include specific radiological medical image analyzers such as computer-assisted detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices will be subject to 510(k) premarket notification. The agency’s final order has special controls (in addition to the general controls) to provide reasonable assurance of device safety and effectiveness. The move also streamlines the review process for CADes to allow patients faster access to these devices.
The final order will be published on the Federal Register on Wednesday, January 22.
The FDA also released the guidance document, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions.