What is FDA's software Documentation Level?

FDA's June 2023 guidance on premarket submissions for device software functions defines two levels, Basic and Enhanced, which determine how much software documentation goes into the submission.

When is Enhanced Documentation needed?

When a failure or flaw of any device software function could present a hazardous situation with a probable risk of death or serious injury, judged before risk controls. Enhanced is also generally recommended for Class III devices, combination products and certain blood-related devices.

Is the Documentation Level the same as the IEC 62304 safety class?

No. The IEC 62304 class can be lowered by risk controls outside the software, but the Documentation Level is assessed before any risk controls, so Class A or B software can still need Enhanced documentation.

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