memo_artifacts_standards_fda_cybersecurity_2023

SysML API

Public namespace	memo::artifacts::standards
Declared package	memo_artifacts_standards_fda_cybersecurity_2023
Source	src/artifacts/standards/fda_cybersecurity_2023.sysml

Namespace hierarchy

memo → memo::artifacts → memo::artifacts::standards

Packages

Package
memo_artifacts_standards_fda_cybersecurity_2023

Imports

Visibility	Target
private	ScalarValues::*
private	memo_core_enumerations::*
private	memo_core_relationships::*
private	memo_artifacts_standards_traceability::*

Declarations

Name	SysML kind	Description	Specializes
—	—	—	—

Source

artifacts/standards/fda_cybersecurity_2023.sysml

// FDA guidance — "Cybersecurity in Medical Devices: Quality System
// Considerations and Content of Premarket Submissions" (September 2023).
//
// Guidance, not a consensus standard, so every clause here carries
// normativeStrength = "informative": FDA guidance describes current thinking
// and is not binding. It is modelled as a RegulatoryStandard all the same,
// because a submission traces to it exactly the way it traces to IEC 62304 —
// the traceability question is identical, only the enforceability differs, and
// that difference is data on the clause rather than a second mechanism.
//
// Reference granularity is the guidance's own lettered section structure
// (IV, V.A, …), not a decimal clause numbering — this document has none. The
// templates previously cited decimal numbers ("3.2", "5.2") that match no
// section of the published guidance; those were replaced when this pack landed.
package memo_artifacts_standards_fda_cybersecurity_2023 {
    private import ScalarValues::*;
    private import memo_core_enumerations::*;
    private import memo_core_relationships::*;
    private import memo_artifacts_standards_traceability::*;

    item fdaCybersecurity2023 : RegulatoryStandard {
        attribute :>> id = "STD-FDA-CYBER-2023";
        attribute :>> name = "FDACybersecurity2023";
        attribute :>> designation = "FDA Cybersecurity Guidance 2023";
        attribute :>> edition = "2023-09";
        attribute :>> issuer = "FDA";
        attribute :>> appliesToRegime = (RegulatoryRegimeKind::FDA_510k, RegulatoryRegimeKind::FDA_PMA);
    }

    item fdaCyberSection4 : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-IV";
        attribute :>> name = "FDACyberSectionIV";
        attribute :>> clauseNumber = "IV";
        attribute :>> title = "general cybersecurity principles";
        attribute :>> normativeStrength = "informative";
    }
    item fdaCyberSection5 : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-V";
        attribute :>> name = "FDACyberSectionV";
        attribute :>> clauseNumber = "V";
        attribute :>> title = "secure product development framework";
        attribute :>> normativeStrength = "informative";
    }
    item fdaCyberSection5A : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-V-A";
        attribute :>> name = "FDACyberSectionVA";
        attribute :>> clauseNumber = "V.A";
        attribute :>> title = "security risk management";
        attribute :>> normativeStrength = "informative";
    }
    item fdaCyberSection5B : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-V-B";
        attribute :>> name = "FDACyberSectionVB";
        attribute :>> clauseNumber = "V.B";
        attribute :>> title = "security architecture";
        attribute :>> normativeStrength = "informative";
    }
    item fdaCyberSection5C : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-V-C";
        attribute :>> name = "FDACyberSectionVC";
        attribute :>> clauseNumber = "V.C";
        attribute :>> title = "cybersecurity testing";
        attribute :>> normativeStrength = "informative";
    }
    item fdaCyberSection6 : StandardClause {
        attribute :>> id = "STD-FDA-CYBER-2023-VI";
        attribute :>> name = "FDACyberSectionVI";
        attribute :>> clauseNumber = "VI";
        attribute :>> title = "cybersecurity transparency and vulnerability management";
        attribute :>> normativeStrength = "informative";
    }

    connection fdaCyberHas4 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection4;
    connection fdaCyberHas5 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection5;
    connection fdaCyberHas6 : Composes connect parent ::> fdaCybersecurity2023 to child ::> fdaCyberSection6;

    connection fdaCyberHas5A : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5A;
    connection fdaCyberHas5B : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5B;
    connection fdaCyberHas5C : Composes connect parent ::> fdaCyberSection5 to child ::> fdaCyberSection5C;
}