Guidance on Premarket Submission for Device Software Functions

This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD) and software as a medical device (SaMD), and summarizes the types of information typically produced during software design, development, verification, and validation.

Documentation Level

The level of documentation required depends on the device’s risk to patients, users, or others in the use environment. FDA evaluates four risk-based factors to determine whether a device requires Basic Documentation or Enhanced Documentation. This classification helps identify the minimum amount of information appropriate for a software‑inclusive premarket submission.

The Documentation Level is determined by the intended use of the device as a whole rather than the intended use of individual software functions. Basic Documentation applies when Enhanced Documentation is not necessary. Enhanced Documentation must be provided when the device’s risk profile warrants it.

Recommended Documentation

Submitted documentation should demonstrate that software development followed structured engineering practices, including traceability, planning, requirements definition, risk assessment, design review, change control, verification and validation testing, and other measures ensuring that the software is properly designed and functions as intended. This information supports FDA’s assessment of whether the device software is safe and effective.

Documentation Level Statement

Submissions should include a clear statement identifying the Documentation Level (Basic or Enhanced) and a justification for the classification.

Software Description

A high-level description of software functionality should be included, supported by diagrams, flowcharts, state charts, and other visuals as needed to explain operationally significant features. For modified devices, the submission should reference prior FDA submissions and highlight relevant software changes since the most recent clearance or approval.

Sponsors may use the guiding questions provided in the draft guidance to ensure complete descriptions, while recognizing that additional device‑specific information may be useful to support FDA’s understanding.

For multiple function device products that contain “other functions,” as described in FDA’s guidance on Multiple Function Device Products, sponsors should incorporate the applicable recommendations from that document when preparing software description materials.