Clinical Decision Support (CDS) software analyzes data within EHRs or directly from devices to help providers make clinical decisions. Some CDS functions are excluded from FDA device regulation under Section 3060 of the Cures Act when criteria are met. Under section 520(o)(1)(E) of the FD&C Act, non-device CDS must not analyze medical images or signals, must display or analyze medical information, must support a healthcare professional's recommendation and must allow the professional to independently review the basis for it. FDA's 2022 final CDS guidance interprets these criteria narrowly; for example, software that gives a single specific output or time-critical alerts is likely to remain a device.

Why it matters

Whether a CDS function is a regulated device depends on transparency of the basis for recommendations and time-criticality of the underlying condition.

Common pitfalls

•A common pitfall is assuming all CDS software is exempt from regulation; only specific functions meeting the Cures Act criteria are excluded.
•Misinterpreting "transparency" can lead to non-compliance, as the basis for recommendations must be clearly understandable by a healthcare professional.
•Failing to consider the time-criticality of the clinical situation for which the CDS is intended can result in incorrect regulatory classification.
•Neglecting to update regulatory assessments when CDS functionalities change can lead to non-conforming products.
•Assuming EU MDR classification is identical to FDA Cures Act exemptions will lead to non-compliance in the EU market.

Sources

FDA CDS Guidance · FDA
IMDRF - Software as a Medical Device · IMDRF
MDCG Software Guidance · MDCG

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Common comparison patterns

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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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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