28 Jun 2025

Regulatory Pathways for SaMD

Posted Byroysr

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SaMD (Software as a Medical Device) refers to software that is intended to be used for medical purposes without being part of a hardware medical device. It performs medical functions—such as diagnosis, disease monitoring, treatment support, or prevention—independently of any physical device. This concept is recognized and defined by regulatory authorities like the International Medical Device Regulators Forum (IMDRF) and is increasingly regulated by agencies such as the FDA (U.S.), EMA (Europe), and others globally. Here we will focus on Regulatory Pathways for SaMD.

Key Characteristics of SaMD:

Standalone Software: Not embedded in a physical device but can run on computers, smartphones, or cloud platforms.
Clinical Purpose: Designed to diagnose, monitor, prevent, or treat diseases.
Platform Independent: May be used across various operating systems and interfaces.

Examples of SaMD:

An app that analyzes heart rhythm data from a smartwatch to detect atrial fibrillation.
AI-powered software that analyzes radiology images to detect cancer.
A digital tool that adjusts insulin dosing recommendations based on real-time glucose monitoring.
A mental health app that uses algorithms to support behavioral therapy.

SaMD Regulatory Pathways and Considerations:

SaMD must comply with medical device regulations, which vary by region:

FDA (U.S.): Regulates SaMD under its Digital Health Framework; classification depends on risk (Class I to III).
EU MDR: SaMD falls under the Medical Device Regulation (MDR) and requires a CE mark.
IMDRF Framework: Offers global harmonization guidance on risk categorization and lifecycle processes.
Data Privacy & Cybersecurity: Must adhere to standards like HIPAA, GDPR, and ISO 27001.