The FDA uses a risk-based approach to determine the Documentation Level, which is classified as either Basic or Enhanced. The Documentation Level serves the purpose of establishing the minimum information necessary to support a premarket submission involving device software functions.

The following are the recommended documentation for each software documentation type, along with its corresponding Documentation Level.

  1.    1. Documentation Level Evaluation:
    1. This document specifies the Documentation Level applicable to the device, indicating the extent of documentation required.

  1.    2. Software Description:

The software description encompasses a comprehensive overview of significant software features, functions, analyses, inputs, outputs, and hardware platforms involved.

  1.    3. Risk Management File:

The risk management file should be provided as part of the premarket submission. FDA recommends referring to an FDA-recognized version of ISO 14971. This document includes (a) Risk management plan, (b) Risk Assessment, (c) Risk Management Report.

  1.    4. Software Requirements Specification (SRS).

The SRS documentation provides a clear and organized description of the system or software needs and expectations.

  1.    5. System and Software Architecture Design:

The documentation includes detailed diagrams illustrating the device's modules, layers, and interfaces.

  1.    6. Software Design Specification (SDS):

SDS is not recommended for Basic level documentation in the premarket submission. However, it is required for Enhanced level submission to provide this document. SDS explains the technical design details, implementation of SRS requirements, and traceability to intended use, functionality, safety, and effectiveness.

  1.    7. Software Development, Configuration Management, and Maintenance Practices:

For Basic level documentation, provide a brief summary of the life cycle development plan and an overview of configuration management and maintenance activities. However, for Enhanced level documentation, a complete comprehensive configuration management plan must be submitted.

An alternative approach for both documentation levels is to submit a "Declaration of Conformity" that aligns with the requirements of IEC 62304.

  1.    8. Software Testing as Part of Verification and Validation:

For Basic level documentation, include a summary of testing activities conducted at the unit, integration, and system levels. However, for Enhanced level documentation, along with the summary, include unit and integration level test protocols that detail expected and observed results, pass/fail determination, as well as corresponding test reports.

  1.    9. Software Version History

A record of tested software versions, specifying the date, version number, and a concise description of all changes made compared to the previous tested software version.

  1.    10. Unresolved Software Anomalies

A report and compilation of outstanding software anomalies, along with an assessment of their respective impact on the device's safety and effectiveness.

For detailed information, refer to the official guidance on Premarket Submissions for Device Software Functions published on the US FDA website.




Content of Premarket Submissions for Device Software Functions