The U.S. Food and Drug Administration has released guidelines on the regulation of computer-assisted detection (CAD) technology. Two new documents, which come more than two years after the agency published draft guidelines in the Federal Register, according to AuntMinnie.com, focus on performance testing for both 510(k) submissions and premarket approval (PMA) applications.
The 510(k) submissions guidance focuses on devices that apply to radiology images and radiology device data, such as images produced via ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or x-ray. It covers "devices marketed as a complete package with a review workstation, or as an add-on software to be embedded within imaging equipment, an image review platform [picture archiving and communications systems], or other imaging accessory equipment."
The other document, meanwhile, focuses on guidance "regarding clinical performance assessment studies for CADe devices applied to radiology images and radiology device data."
The FDA chose to focus only on computer-assisted detection (CADe) technology, and not computer-assisted diagnosis (CADx) technology.
CAD technology can be used in identifying and treating cancer, specifically breast cancer, although some researchers have expressed skepticism about its effectiveness. Mammography CADe algorithms are listed in the latter document, but not the former, according to AuntMinnie.com.
At least one CAD vendor--Medipattern--seemed excited about the FDA's efforts. CEO Jeff Collins told AuntMinnie.com that the new guidance has helped to "resolve confusion" as CAD technology has evolved.
The FDA has been busy of late, also issuing a proposed rule for unique device identifiers last week.
To learn more:
- read this AuntMinnie.com article (registration required)
- here's the 510(k) guidance (.pdf)
- here's the PMA guidance (.pdf)