FDA CDRH’s guidance “Non-invasive Pulse Oximeter” for 510(k) review drafted Sept 7, 1992 and posted on the FDA website June 2000. This guidance mentions software specifically in several places (the link provided is for the full guidance) the most significant being:
“I. Is the device Software-driven? Yes/No
The firm should provide a hazard analysis, software requirements and design information, adequate test plans/protocols with appropriate data and test reports, documentation of the software development process including quality assurance activities, configuration management plan, and verification activities and summaries, commensurate with the level of concern, as discussed in the “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review”. The software of a pulse oximeter is a major level of concern. The hazard analysis and the most recent software version should be included in the file.”
7. Is the device solid-state controlled and hard-wired or does the device contain a microprocessor? Does the microprocessor controlled device conform to the moderate software concern guidance document?
C. Alarms …
3. If the device is software controlled, is there an alarm package for microprocessor failure? Is the design fail-safe; Is there an alarm alarm?”