The Radiological Devices Panel met on March 4 and 5 to provide consensus advice to the FDA regarding computer-aided detection (CAD) devices for radiological images, such as mammograms, chest x-rays, and CT images of the lungs and colon.
Sharon Burgess, policy analyst, office of the center director, Center for Devices and Radiological Health, told Health Imaging News that the CDRH is contemplating the results of the panel’s discussion to work through the appropriate follow-up activities.
“As discussed [at the meeting], CDRH is considering the development of a guidance document for CAD devices for radiological images,” Burgess noted in an e-mail. “CDRH will review the information presented at the panel meeting and take it into consideration as we consider the development of a guidance document.” Burgess added that if a document is developed, it will be distributed for public comment before it is finalized.
During the meeting, the panel provided specific advice for mammography CAD devices, colon CAD devices, and lung CAD devices with focus on appropriate ground truth, the relative roles of standalone and reader performance testing for the clinical evaluation of these devices, suggestions of other types of performance testing, enrichment of clinical study datasets, clinical study designs that account for different reader paradigms, and the impact of a device’s indications for use on the clinical study design and device labeling.
The draft of a Level 1 guidance document will describe the types of data necessary to characterize CAD performance for future marketing applications, according to CDRH.
CDRH has posted the standard 24-hour/brief summary online.