Human Factors: Premarket Information - Device Design and Documentation Processes
On this page:
- Human Factors Information Contained in a Marketing Submission
- Support for Appropriate Application of Human Factors Methods to Medical Device Design
Human Factors Information Contained in a Marketing Submission
Device manufacturers should follow the risk-based approach described in the FDA guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” to determine the level of human factors information to include in a marketing submission to the Center for Devices and Radiological Health (CDRH). The level of human factors information is defined by the Human Factors (HF) Submission Category.
Support for Appropriate Application of Human Factors Methods to Medical Device Design
Quality Management System Regulation
Medical device manufacturers are required to comply with the Quality Management System Regulation, 21 CFR Part 820. In particular, the design and development requirements of 21 CFR 820.10(c) and ISO 13485 Clause 7.3 and its subclauses include requirements relevant to human factors.
- Quality Management System Regulation (QMSR)
- Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
FDA-Recognized Consensus Standards on Human Factors
FDA has officially recognized device-specific and general consensus standards published by national and international standards bodies. Standards recognized by FDA related to human factors and application of HFE/UE to medical devices are listed below. For the current edition of the FDA-recognized consensus standards as well as the extent of recognition, see the FDA Recognized Consensus Standards Database.
| Standard | Title | Main Purpose |
|---|---|---|
| AAMI/ANSI HE75 | Human factors engineering – Design of medical devices | Comprehensive reference that includes general principles, management of use error risk, design elements, integrated solutions |
| ANSI/AAMI/IEC 62366 | Medical devices – Part 1: Application of usability engineering to medical devices | HFE/UE process applied to all applying HF/usability to medical device design, with consideration of risk management |
| ANSI/AAMI/ISO 14971 | Medical devices – Application of risk management to medical devices | Risk management process for medical devices |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability | Provides a bridge between IEC 60601-1 and ANSI/AAMI/IEC 62366 |
| IEC 60601-1-8 | Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Design standard for alarm systems in medical electrical equipment and systems |
| IEC 60601-1-11 | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Basic safety and essential performance for medical electrical equipment used in non-clinical environments, including issues involving medical device use by lay users |
FDA - Guidance Documents Related to Human Factors
FDA has developed several guidance documents to support device manufacturers in applying appropriate human factors methods in the design of their products. These include:
- Applying Human Factors and Usability Engineering to Medical Devices
- Content of Human Factors Information in Medical Device Marketing Submissions
- Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
To find more information about other available guidances, please see FDA’s website on Guidance Documents (Medical Devices and Radiation-Emitting Products).