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    Common Weakness Enumeration

    Community-maintained list of software and hardware weakness types, the underlying defects that cause CVEs.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    Common Weakness Enumeration (CWE) is a category system for software and hardware weaknesses maintained by MITRE on behalf of CISA. While a CVE identifies a specific vulnerability in a specific product, a CWE identifies the underlying weakness type, for example, CWE-79 (Cross-Site Scripting), CWE-89 (SQL Injection), CWE-787 (Out-of-bounds Write), CWE-798 (Use of Hard-coded Credentials). The annual CWE Top 25 Most Dangerous Software Weaknesses ranks the most consequential weakness classes based on prevalence and severity in published CVEs.
    What the regulation says
    CWE mappings can help organize secure-coding and testing evidence. Do not claim an explicit FDA Top 25 citation or a specific IEC 81001-5-1 clause requirement without the original passage.

    What this means in practice

    Normalize applicable analysis findings to CWE where feasible and link them to secure-development controls. A Top 25 mapping alone does not demonstrate IEC 81001-5-1 conformance.

    Examples

    • Illustrative: A developer accidentally hard-codes a default password into a device's firmware, which is an instance of CWE-798 (Use of Hard-coded Credentials).
    • Illustrative: During a security audit, a static analysis tool flags several instances of uncontrolled format string vulnerabilities, identifying them as CWE-134.
    • Illustrative: A team designing a new patient monitoring system reviews the CWE Top 25 to prioritize training on preventing common software weaknesses like CWE-79 (Cross-Site Scripting) in their web interface.
    Common pitfalls
    • •Reporting SAST findings as raw tool output without normalizing to CWE, reviewers can't compare evidence across tools without it.
    • •The CWE Top 25 is not exhaustive. Pin examples to a named edition: CWE-798 is included in the 2025 Top 25, so it is not a valid example of a weakness outside that edition.
    • •Conflating CWE with CVE, CWE is the class of defect, CVE is one occurrence of it in a specific product.

    Frequently asked questions

    A CVE identifies a vulnerability record; CWE identifies a weakness type. A vulnerability may have one or more CWE mappings, but mappings may be missing, insufficiently specific or incomplete.
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    Where this term appears across MedTech Terms.

    Sources

    5 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Official-source claim check:

    CWE classifies weakness types rather than individual vulnerabilities; Top 25 is a ranked subset.

    Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.

    Remaining verification limits
    • Secondary regulatory, standards-clause, market-prevalence or procurement claims were not fully substantiated by accessible original text.
    Tier 2Regulator guidance and consensus· 5
    Link health: 3 verified 2 unchecked· last checked 2026-06-20
    MITRE·3MDCG·1FDA·1
    1. 1
      Common Weakness Enumeration
      Tier 2 Verified
      MITREcwe.mitre.org
    2. 2
      CWE Top 25 Most Dangerous Software Weaknesses
      Tier 2 Verified
      MITREcwe.mitre.org
    3. 3
      MDCG Cybersecurity Guidance
      Tier 2 Verified
      MDCGhealth.ec.europa.eu
    4. 4
      MITRE 2025 Top 25
      Tier 2 Unchecked
      MITREcwe.mitre.org
    5. 5
      FDA final guidance, February 3, 2026
      Tier 2 Unchecked
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.