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Medical Devices

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Information for Manufacturers and Distributors

Medical device manufacturers are required to follow FDA’s Human Factors guidance and regulations to help ensure safe use of these devices.

You may also find Other Human Factors Resources helpful.

Quality System/Design Control Regulation
Human Factors Guidance
FDA Recognized Standards
FDA Medical Device Labeling Information

Quality System/Design Control Regulation

Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation

Human Factors Implications of New GMP Rule; Overall Requirements of the New Quality System Regulation

Design Control Guidance For Medical Device Manufacturers

Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff

FDA Human Factors Guidance

Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management

Human Factors Points to Consider for IDE Devices

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA Reviewers and Industry (see Verification and Validation Section)

FDA Recognized Standards

ISO 14971-1:2007 Medical Devices - Application of Risk Management to Medical Devices

AAMI/ANSI HE74:2001 Human Factors Design Process for Medical Devices

IEC 60601-1-8, Ed. 1, Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidelines - General Requirements and Guidelines for Alarm Systems in Medical Equipment.

FDA Medical Device Labeling Information

Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers

Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices used in Home Health Care

Labeling requirements from Device Advice

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