You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit e lectronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
When final, this document will supersede Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (Issued July 18, 2000).
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Additional copies are available from the Internet. You may also send an e-mail request to firstname.lastname@example.org to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1757 to identify the guidance you are requesting.
Table of Contents
- 1. Introduction
- 2. Scope
- 3. Overview
- 4. Regulations, Guidance Documents, and Standards for HFE/UE
- 5. Device Users, Use Environments and User Interfaces
- 5.1 Device Users
- 5.2 Device Use Environments
- 5.3 Device User Interfaces
- 6. Analytical Methods for Identifying, Evaluating and Understanding Use-Related Hazards
- 6.1 Identification of Known Problems
- 6.2 Analytical Approaches to Hazard Identification and Task Prioritization
- 6.2.1 Contextual Inquiry
- 6.2.2 Interviews and Focus Groups
- 6.2.3 Function and Task Analysis
- 6.2.4 Heuristic Analysis
- 6.2.5 Expert Review
- 7. Formative Evaluations
- 7.1 Cognitive Walk-Through
- 7.2 Simulated Use Testing
- 8. Mitigation and Control of Use-Related Hazards
- 9. Design Verification Testing
- 10. Human Factors Validation Testing
- 10.1 Simulated Use Validation Testing
- 10.1.1 Tasks and Use Scenarios
- 10.1.2 Test Participants (Subjects)
- 10.1.3 Participant Training
- 10.1.4 Data Collection
- 10.1.5 Interpretation of Validation Test Results and Addressing Problems
- 10.2 Clinical Validation Testing
- 10.1 Simulated Use Validation Testing
- 11. Documentation
- 12. Conclusion
- Appendix A
- Appendix B
- Appendix C
Draft Guidance for Industry and Food and Drug Administration Staff
Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design
|This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.|
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1 21 CFR 820.30
2 See Draft Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions, released on April 23, 2010. When final, this will represent FDA’s guidance on this topic.
3 21 CFR §820.250
4 Clinical studies must comply with the Investigational Device Exemption requirements set out in 21 CFR §812.
5 e.g., Virzi, 1992; Nielsen, 1993