What does the US FDA expect in a premarket submission for description of the software design? In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance.
For lower risk devices, the manufacturer is not required to send any software design specification documentation. Be aware that the agency could still ask for software design information during the clearance or approval process. Also keep in mind that even though not required in the regulatory submission, software design specifications could likely be reviewed during an FDA regulatory inspection.
For device software functions where a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, more documentation is required and, in particular, software design specifications are required. How much more? Here are the key expectations for software design specification documentation.
Can be one or more documents. Documentation should include:
- Software functionality
Functionality should be described in context of the high level defined in the system and software architectural documentation. - How the software design implements the SRS
- Trace of software design to the SRS in terms of:
- Intended use
- Functionality
- Safety and effectiveness
FDA makes clear that software design is expected to have “occurred as a prospective activity where the SDS was used to guide the design, development and testing of the software rather than documented retrospectively after the software design has been implemented by ad hoc design methods.”
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