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

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.

Why it matters

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).

Sources

Changes to Software Policies (Section 3060) Guidance · FDA
FD&C Act §520(o) · Cornell Law
IMDRF - Software as a Medical Device · IMDRF
FDA September 2022 MDDS guidance · FDA

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Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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