FDA published a draft guidance ” Pulse Oximeters – Premarket Notification Submissions [510(k)s]”. that contains references to software as well as risk control measures and alarms.

In terms of software it states that the software in these devices is generally considered “moderate” level of concern and then references the “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and the guidance, Off-the-Shelf Software Use in Medical Devices” to determine information to be submitted.

Other sections of the guidance do not mention software specifically but some of the testing requirements for performance may be relevant to planning software testing.