Premarket Information - Device Design and Documentation Processes
- Brief Description of Human Factors Pre-Market Review Process
- HFE/UE Validation Report Contained in a Premarket Application or Submission
- Support for Appropriate Application of Human Factors Methods to Medical Device Design
- Resources on Human Factors Considerations for Specific User Populations
The Human Factors Premarket Evaluation Team serves as consultants on the multi-disciplinary review team of various premarket submissions in CDRH and in other Centers within FDA. The team is responsible for evaluating use-related risk analyses, and human factors/usability information and validation study data included in the submission. The team provides recommendations to the multi-disciplinary review team on human factors evaluation of manufacturers' design validation documents as required by the Quality System Regulation (see HFE/UE Validation Report section). The recommendations are reviewed and incorporated in FDA letters to the device manufacturers.
The team responds to device manufacturers’ requests for advice on how best to conduct human factors evaluation and testing. The team works with manufacturers to resolve human factors deficiencies contained in premarket submissions via teleconference or face to face meeting.
A HFE/UE report included in a premarket approval application (PMA), or as requested by FDA for a premarket notification [510(k)] submission under certain circumstances, should provide information pertaining to device use safety in summary form. The level of detail of documentation submitted should be consistent with the nature of the use-related hazards for the device. The information that should be included in the report is shown in the table below.
|1||Intended device users, uses, use environments, and training |
|2||Device user interface |
|3||Summary of known use problems |
|4||User task selection, characterization and prioritization |
|5||Summary of formative evaluations |
|6||Validation testing |
The <device name/model> has been found to be reasonably safe and effective for the intended users, uses and use environments.
- Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
- 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 recognizes the following U.S. and international standards that should be followed to conduct appropriate human factors/usability methods for device design development and assessment.
- ISO 14971-1:2007 Medical Devices - Application of Risk Management to Medical Devices
- AAMI / ANSI HE75:2009, Human Factors Engineering - Design of Medical Devices (General)
- IEC 60601-1-8 Ed. 1, Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidance - General Requirements and Guidelines for Alarm Systems in Medical Equipment (General)
- ISO 62366, Medical Devices - Application of Usability Engineering to Medical Devices
FDA has developed several guidance documents to support device manufacturers to apply appropriate human factors methods in the design of their products.
- New 2011 CDRH Human Factors Guidance
When designing new medical devices, manufacturers should follow good risk management and human factors practices to ensure that their products will be safe and effective for the intended users. Information regarding FDA’s requirements and expectations for these practices is contained in the following human factors/usability engineering guidance document (updated 2011): Applying Human Factors and Usability Engineering to Optimize Medical Device Design
- Human Factors Points to Consider for IDE Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
- Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
- Labeling requirements from Device Advice
- FDA - Pediatric Medical Devices
- U.S. Department of Justice - ADA (Americans with Disabilities Act) Home Page
- ADA Standards Home Page
- U.S. Access Board - Accessible Medical Diagnostic Equipment
- Section 508.gov (Section 508 of the Rehabilitation Act)
- Section 508 Home Page
- Web Accessibility Initiative
- The Principles of Universal Design
- Standards.gov - Assistive Technology
- AbleData (Assistive Technology Information)
- Trace Center, University of Wisconsin website on Designing a More Usable World; contains many links on additional resources, including guidelines based on disability type (e.g., Blindness) and extensive reference listings
- National Public Website on Assistive Technology