Software as a Medical Device
Software intended for medical purposes that performs without being part of a hardware device.
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 clinical decision support systems. IMDRF risk categorization (I to IV) considers the state of the healthcare situation (non-serious, serious, critical) and the significance of the information the SaMD provides (inform, drive, treat or diagnose). Regulators worldwide, including FDA, MHRA, and Health Canada, align to the IMDRF framework.Examples
- A mobile app that analyzes retinal images to screen for diabetic retinopathy without connecting to hardware.
- A cloud service that triages CT scans and flags suspected large-vessel occlusion strokes for radiologist review.
- AI software that estimates ejection fraction from standard echocardiograms.
Use cases
1 scenarioMobile 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.
- •Confusing SaMD with SiMD. If the software is embedded in or required to operate a hardware device, it is SiMD and regulated with the parent device.
- •Assuming a wellness app is out of scope. Once the intended use includes diagnosis, treatment, cure, mitigation, or prevention, the software is likely SaMD.
- •Skipping IEC 62304 lifecycle documentation because the product feels like a normal SaaS release cycle.
- •Treating model updates as bug fixes. Retrained AI models often require a Predetermined Change Control Plan or a new submission.
Frequently asked questions
Cross-references
Governed by
Regulations or standards this term must comply with.
Often confused with
Distinct concept frequently mistaken for this one.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
Software embedded in or required to operate a hardware medical device.
Software providing healthcare professionals with knowledge and patient-specific information.
Lifecycle requirements for medical device software.
SaMD & AI/ML Devices
· From this learning pathGuiding principles for the development of AI/ML-enabled medical devices.
Software not developed for medical device use, or lacking adequate development records, incorporated into a device.
IEC 62304 classes A, B, C reflecting potential harm from software failure.
Ability of devices and systems to exchange and use information.
Software Team Onboarding
· From this learning pathThe federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.
A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
AI/ML Devices Deep Dive
· From this learning pathLarge pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting.
Medical device that uses artificial intelligence or machine learning to perform its intended use.
Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction.
Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow.
Mentioned in recent activity
2 entriesLatest in MedTech
Recent regulatory actions, publications, and trials matched to this term. Updated daily.
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PubMed2026-05-22Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care.
BMJ health & care informatics
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PubMed2026-05-11Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device.
BMC proceedings
Primary references
3 sources- 1
IMDRF SaMDVerifiedIMDRFimdrf.org
- 2
FDA SaMD ResourcesVerifiedFDAfda.gov
- 3
FDA - AI/ML-Enabled Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.