FDA review of software: discussion of the proposed reviewer´s guide

The widespread application of microprocessors to medical devices has led to a need by FDA for internal reviewer guidance that will establish uniform review criteria for software. A software committee in the Center for Devices and Radiological Health (CDRH) was created to establish a reviewer´s guidance document for computer-controlled medical devices. A guidance document was drafted by the committee and distributed to industry associations for comment. The proposed guidance document presents an overview to the reviewer as to (1) the kind of information to expect, and (2) the approach to take in reviewing computer-controlled medical devices. Extracts from the first three sections of the document are presented