FDA CDRH’s “Guide for Oxygen Conserving Device 510(k) Review” was considered obsolete as of 12/21/01 and may be used for historical purposes
Drafted Feb 1989 and posted on the FDA website June 2000. This guidance mentions software specifically in two places (the link provided is for the full guidance):
” B. Specification Criteria …
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?”