All terms
Software as a Medical Device
Software intended for medical purposes that performs without being part of a hardware device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Per IMDRF, Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.What this means in practice
SaMD spans diagnostic apps, AI triage tools, and CDS systems. IMDRF risk categorization (I–IV) considers the state of the healthcare situation and the significance of the information provided by the SaMD.Use cases
1 scenario1
Mobile app analyzing skin lesions for melanoma risk
Founder / RAThe app meets the FDA SaMD definition. The team applies IMDRF risk categorization, follows IEC 62304 for software lifecycle, and uses GMLP principles for the underlying model. They submit a 510(k) with a cleared dermatology AI as predicate.
OutcomeThe product launches as a regulated Class II SaMD with a clear update pathway via a Predetermined Change Control Plan.
Cross-references
Governed by
Regulations or standards this term must comply with.
Often confused with
Distinct concept frequently mistaken for this one.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
IMDRF·1FDA·2
- 1
IMDRF SaMDVerifiedIMDRFimdrf.org
- 2
FDA SaMD ResourcesVerifiedFDAfda.gov
- 3
FDA - AI/ML-Enabled Medical DevicesVerifiedFDAfda.gov
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