The Food and Drug Administration (FDA) has issued three final orders with accompanying codifying regulatory changes to reclassify into Class II certain medical imaging-related devices, paving the way for a more streamlined process for affected manufacturers to achieve FDA clearance for these devices.
The orders, published in the Jan. 22, 2020 issue of the Federal Register, addressed classification, special controls and product labeling for “Computer Aided Triage and Notification Software,” “Medical Image Analyzers” and “Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer.”
The applicable regulatory requirements would apply to these devices consistent with the regulatory definitions as quoted below:
Radiological Computer Aided Triage and Notification Software
Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight or direct users' attention to a specific location in the original image. The device does not remove cases from reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.
Medical Image Analyzers
Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.
Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer
A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.
The FDA intends that the new classification of these types of devices and associated streamlined review will provide patients with more timely access to this technology.