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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
Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule;
Quality System Regulation |
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Human Factors Implications of New GMP Rule; Overall Requirements of the
New Quality System Regulation |
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Design Control Guidance For Medical Device Manufacturers |
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Quality System Information for Certain Premarket Application Reviews;
Guidance for Industry and FDA Staff |
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FDA Human Factors Guidance
Medical Device Use-Safety: Incorporating Human Factors Engineering
into Risk Management |
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Human Factors Points to Consider for IDE Devices |
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA Reviewers and Industry (see Verification and Validation Section) |
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FDA Recognized Standards
ISO 14971-1:2007 Medical Devices - Application of Risk Management to Medical Devices |
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AAMI/ANSI HE74:2001 Human Factors Design Process for Medical Devices |
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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. |
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FDA Medical Device Labeling Information
Guidance on Medical Device Patient Labeling; Final Guidance
for Industry and FDA Reviewers |
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Checklist: Medical Device Patient Labeling |
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Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices used in Home Health Care |
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Labeling requirements from Device Advice |
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Updated October 14, 2008 |