New Final FDA Guidance on Content of Premarket Submissions for Device Software Functions

Software Documentation Elements

Basic Documentation Level

Enhanced Documentation Level

Documentation Level Evaluation

Statement of Documentation Level and rationale

Software Description

Overview of significant software features, functions, analyses, inputs, outputs, and hardware platforms

Risk Management File

Risk management plan, assessment, and report.

Software Requirements Specification (SRS)

SRS with sufficient information to understand traceability to risk management, SDS, architecture design, and testing.

System and Software Architecture Design

Diagrams of the device modules, layers, and interfaces, their relationships, data flows, and user interactions.

Software Design Specification (SDS)

N/A

SDS that details how the design implements and is traceable to the SRS

Software Development, Configuration Management, and Maintenance Practices

Summary of the life cycle development plan, configuration management and maintenance activities

OR

Declaration of Conformity to IEC 62304

Basic documentation PLUS complete configuration management and maintenance plan(s)

OR

Declaration of Conformity to IEC 62304

Software Testing as Part of Verification and Validation

Summary of unit, integration, and system testing.

AND

System level test protocol and report.

Basic documentation PLUS unit and integration level test protocols and reports.

Software Version History

History of tested versions including date, version number, and change descriptions

Unresolved Software Anomalies

List of software anomalies and evaluation of device’s safety and effectiveness.