Intended Use & FDA Safe Harbor

    Formal Classification and Usage Guidelines

    Intended Use Statement

    Solution Compass is designed and intended solely for operational knowledge managementand administrative support within healthcare and other organizational environments.

    The platform is specifically intended for:

    • Organizing and retrieving institutional policies and procedures
    • Managing operational workflows and administrative documentation
    • Facilitating access to organizational knowledge bases
    • Supporting non-clinical decision-making processes
    • Training and educational resource management

    FDA Safe Harbor Classification

    Under the 21st Century Cures Act (Public Law 114-255, Section 3060), Solution Compass qualifies for FDA Safe Harbor protection as it does not meet the definition of a medical device software function.

    This software is excluded from FDA medical device regulations because it:

    • Is not intended for use in the diagnosis of disease or other conditions
    • Is not intended for use in the cure, mitigation, treatment, or prevention of disease
    • Does not analyze patient-specific medical device data
    • Does not provide clinical recommendations or treatment guidance

    Legal Reference: 21 USC 360j(o)(1)(A) - Administrative support software functions

    Prohibited Uses

    Solution Compass is NOT intended for and must NOT be used for:

    • Clinical diagnosis or treatment recommendations
    • Patient care decision-making
    • Medical device data interpretation
    • Drug dosing or medication management
    • Clinical protocol development
    • Patient safety alerts or clinical decision support
    • Any function that could influence clinical outcomes

    Professional Responsibility

    Healthcare professionals and organizational users retain full responsibility for:

    • All clinical decisions and patient care
    • Compliance with applicable medical standards and regulations
    • Verification of any operational information before implementation
    • Maintaining appropriate professional judgment in all activities

    Important: This software provides organizational support only. All clinical decisions must be made by qualified healthcare professionals using appropriate clinical judgment and established medical protocols.

    Legal Disclaimer

    This intended use statement is effective as of the date of publication and supersedes any previous versions. The classification and intended use may be updated to reflect changes in applicable regulations or software functionality.

    For questions regarding this intended use statement or FDA compliance, please contact our compliance team through the official support channels.

    Last Updated: August 28, 2026