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    Software & AISoftware LifecycleGlobal MarketsMDDS

    Medical Device Data System

    Software data-transfer, storage, format-conversion and display functions excluded from device status; qualifying hardware follows a separate FDA policy.

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

    Definition

    Software functions solely intended to transfer, store, convert formats, or display medical device data and results are excluded under section 520(o)(1)(D), subject to the statutory limitations. Qualifying MDDS hardware remains a device, but FDA’s September 2022 policy states it does not intend to enforce applicable requirements for hardware limited to assisting these functions. Interpretation, analysis, active patient monitoring, or control requires separate assessment; falling outside this exclusion does not automatically establish device status or a premarket submission requirement. Assess functions separately in multifunction products.
    What the regulation says
    Software functions solely intended to transfer, store, convert formats, or display medical device data and results are excluded under section 520(o)(1)(D), subject to the statutory limitations. Qualifying MDDS hardware remains a device, but FDA’s September 2022 policy states it does not intend to enforce applicable requirements for hardware limited to assisting these functions. Interpretation, analysis, active patient monitoring, or control requires separate assessment; falling outside this exclusion does not automatically establish device status or a premarket submission requirement. Assess functions separately in multifunction products.

    What this means in practice

    Software functions solely intended to transfer, store, convert formats, or display medical device data and results are excluded under section 520(o)(1)(D), subject to the statutory limitations. Qualifying MDDS hardware remains a device, but FDA’s September 2022 policy states it does not intend to enforce applicable requirements for hardware limited to assisting these functions. Interpretation, analysis, active patient monitoring, or control requires separate assessment; falling outside this exclusion does not automatically establish device status or a premarket submission requirement. Assess functions separately in multifunction products.

    Examples

    • Illustrative: A hospital's central server collects and stores vital sign measurements from various patient monitors for archival purposes, without performing any analysis or generating alerts.
    • Illustrative: A smartphone application receives and displays glucose readings from a connected continuous glucose monitor, allowing the user to view their trend over time but not offering interpretive insights or treatment recommendations.
    • Illustrative: A software module converts data from an infusion pump into a standardized format for integration into an electronic health record system, purely facilitating data exchange without altering device operation or interpreting clinical significance.
    Common pitfalls
    • •Claiming MDDS for software that interprets data, analytics, alarms, scoring, and clinical recommendations are not MDDS.
    • •Letting MDDS scope creep without re-evaluation, features added over time can shift the product across the regulatory boundary.
    • •Confusing MDDS with Clinical Decision Support (CDS), they are different exclusions with different criteria under §520(o).

    Frequently asked questions

    Software functions solely intended to transfer, store, convert formats, or display medical device data and results are excluded under section 520(o)(1)(D), subject to the statutory limitations. Qualifying MDDS hardware remains a device, but FDA’s September 2022 policy states it does not intend to enforce applicable requirements for hardware limited to assisting these functions. Interpretation, analysis, active patient monitoring, or control requires separate assessment; falling outside this exclusion does not automatically establish device status or a premarket submission requirement. Assess functions separately in multifunction products.

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    Sources

    4 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:

    Sole transfer/storage/format-conversion/display software functions are excluded from device definition; qualifying hardware remains a device subject to enforcement discretion.

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

    Remaining verification limits
    • Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.
    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 3
    Link health: 3 verified 1 unchecked· last checked 2026-06-20
    FDA·2Cornell Law·1IMDRF·1
    1. 1
      Changes to Software Policies (Section 3060) Guidance
      Tier 2 Verified
      FDAfda.gov
    2. 2
      FD&C Act §520(o)
      Tier 1 Verified
      Cornell Lawlaw.cornell.edu
    3. 3
      IMDRF - Software as a Medical Device
      Tier 2 Verified
      IMDRFimdrf.org
    4. 4
      FDA September 2022 MDDS guidance
      Tier 2 Unchecked
      FDAfda.gov

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