Date Published:
Wed, 10/21/2009The CDRH branch of the US FDA issued this draft guidance document for comment on October 21, 2009. This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data.
See section 4 for recommendations regarding validation of analysis software.