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


  • On June 14, 2023, FDA published a new version of the premarket software guidance document which replaces the 2005 version.
  • The new final guidance takes a simplified risk-based approach to help determine the device's Documentation Level, which is either Basic or Enhanced.
  • The newly recommended information outlined in this guidance will not be required during review of submissions received through August 13, 2023. CDRH does, hoewever, intend to review any such information if submitted.

Read the full guidance.

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)


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


Declaration of Conformity to IEC 62304

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


Declaration of Conformity to IEC 62304

Software Testing as Part of Verification and Validation

Summary of unit, integration, and system testing.


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.


Related Guidance Update

The FDA intends to issue minor updates to the guidance Off-The-Shelf Software Use in Medical Devices as well as to certain device specific guidances to reflect and ensure consistency with the information conveyed within the final guidance.

Upcoming webinar on this guidance

On July 20, 2023, the FDA will host a webinar for medical device manufacturers and other stakeholders interested in learning more about the final guidance and the recommendations for documentation sponsors should include in premarket submissions. 

Learn more about Qserve US Market Access services and schedule your free consultation to see how our experts can help bring into United States Market. 

Michelle Hasse, MSc
Post date: June 15, 2023
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