FDA CDRH 510(k) Guidance Nitric Oxide Devices

“Guidance Document for Premarket Notification Submissions for Nitric> Delivery Apparatus, Analyzer and Nitrogen Dioxide Analyzer” issued Jan 24, 1999. This guidance has several references to software including a section on software information. The entire guidance is attached and the software-specific section is Section 9. It is interesting to note that it requests information on what V&V was done before and after integration with hardware and it specifically asks for the most recent test results and emphasizes the need to include the software version level associated with the final design of the device.