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U.S. Department of Health and Human Services

Advisory Committees

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Radiological Devices Panel Meeting - March 4 and 5, 2008

The Radiological Devices Panel met on March 4 and 5, 2008, to provide consensus advice to the U.S. Food and Drug Administration (FDA) regarding computer aided detection (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography images of the lungs and colon. Questions on the general methodologies for CAD, including how CAD devices are used in clinical decision making, how the devices are tested, ways to avoid or account for statistical biases, and what information is needed to properly assess their safety and effectiveness were discussed. 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 (e.g., radiologist reading images with CAD after an unaided reading vs. concurrent CAD reading), and the impact of a device’s indications for use on the clinical study design and device labeling.

The Panel Chair led discussions on mammography, colon, lung, and general/future CAD issues. At the end of each discussion, he provided a summary of the Panel’s consensus opinion. Open Public Hearing sessions, held in the morning and afternoon sessions on both days, provided the public an opportunity to provide input. Most of the firms in this segment of the industry provided input, as did academic researchers and NCI speakers. Because the technology of CAD devices is evolving, the Agency sought this input from the Panel and the public in preparation for the drafting of a Level 1 guidance document that will describe the types of data necessary to characterize CAD performance for future marketing applications.

Contact: Nancy Wersto, Executive Secretary, at 240-276-3666 or nancy.wersto@fda.hhs.gov .

Transcripts may be purchased from: (written requests only)
Neal R. Gross & Company
1323 Rhode Island Ave., NW
Washington, DC 20008
(202) 234-4433 (voice), (800) 473-1433
Or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice), (301) 443-1726 (fax)