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Resources for SaMD Developers

U.S. Food & Drug Administration

FDA Premarket Notification 510(k) Guidance: Selecting and Preparing the Correct Submission for Medical Devices

FDA CFR Title 21 Part 820: Quality System Regulation for Medical Devices

FDA CFR Title 21 Part 11: Electronic Records and Electronic Signatures Requirements

FDA Training and Continuing Education Platform for Medical Devices and Radiological Health Topics (CDRH Learn)

FDA Digital Health Center of Excellence: SaMD Overview and Resources

FDA Overview: AI/ML-Enabled Medical Devices

FDA Guidance: AI/ML in SaMD

FDA Guidance: Good ML Practice for Medical Device Development – Guiding Principles

European Union

Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ Obligations

Implementation Module for Medical Devices Regulation: Step by Step Guide

Factsheet for Manufacturers of Medical Devices

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

MDR and IVDR Introductory Guide – MHRA

Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices

Health Canada

Medical Devices Regulations SOR/98-282

Guidance Document: Software as a Medical Device (SaMD): Definition and Classification

Medical Device Coordination Group (MDCG)

Infographic: Is your software a Medical Device?

Guidance on Qualification and Classification of Software in EU 2017/745 – MDR and 2017/746 – IVDR

International Medical Device Regulators Forum (IMDRF)

Technical Document – Software as a Medical Device (SaMD): Key Definitions

Technical Document – Software as a Medical Device (SaMD): Clinical Evaluation

Technical Document – Software as a Medical Device (SaMD): Application of Quality Management System

Technical Document – Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

Technical Document – Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

International Organization for Standardization (ISO)

ISO 9001:2015 – Quality management systems – Requirements

SO 13485:2016 – Medical devices – Quality management systems – Requirements

ISO 14971:2019 – Medical devices – Application of risk management to medical devices