OnGuard Chest x-ray CAD device. Image source: Riverain Medical

The FDA has issued two draft guidance documents concerning the premarket approval (PMA) process for computer-assisted detection (CAD) devices, which are available for public comment.

The first guidance,“CAD Devices Applied to Radiology Images and Radiology Device Data--Premarket Notification [510(k)] Submissions,” provides recommendations regarding premarket notification (510(k)) submissions of certain CAD devices applied to radiology images and radiology device data.

The second draft guidance, “Clinical Performance Assessment: Considerations for CAD Devices Applied to Radiology Images and Radiology Device Data--Premarket Approval and Premarket Notification [510(k)] Submissions,” provides recommendations on how to design and conduct clinical performance studies for CAD devices applied to radiology images and radiology device data. These studies may be part of a premarket submission to the FDA, whether it is a 510(k) submission, an application for PMA, an application for a humanitarian device exemption or an application for an investigational device exemption.

These draft guidances are not final nor are they currently in effect, according to the agency.

Written or electronic comments on the draft guidances must be submitted by Jan. 19, 2010.