Medical Devices

Premarket Information - Device Design and Documentation Processes

Brief Description of Human Factors Pre-Market Review Process

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.

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HFE/UE Validation Report Contained in a Premarket Application or Submission

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.

1Intended device users, uses, use environments, and training
  • Intended user population(s) and critical differences in capabilities between multiple user populations
  • Intended uses and operational contexts of use
  • Use environments and key considerations
  • Training intended for users and provided to test participants
2Device user interface
  • Graphical depiction (drawing or photograph) of device user interface
  • Verbal description of device user interface
3Summary of known use problems
  • Known problems with previous models
  • Known problems with similar devices
  • Design modifications implemented in response to user difficulties
4User task selection, characterization and prioritization
  • Risk analysis methods
  • Use-related hazardous situation and risk summary
  • Critical tasks identified and included in HFE/UE validation tests
5Summary of formative evaluations
  • Evaluation methods
  • Key results and design modifications implemented
  • Key findings that informed the HFE/UE validation testing protocol
6Validation testing
  • Rationale for test type selected (i.e., simulated use or clinical evaluation)
  • Number and type of test participants and rationale for how they represent the intended user populations
  • Test goals, critical tasks and use scenarios studied
  • Technique for capturing unanticipated use errors
  • Definition of performance failures
  • Test results: Number of device uses, success and failure occurrences
  • Subjective assessment by test participants of any critical task failures and difficulties
  • Description and analysis of all task failures, implications for additional risk mitigation
The <device name/model> has been found to be reasonably safe and effective for the intended users, uses and use environments.
  • The methods and results described in the preceding sections support this conclusion.
  • Any residual risk that remains after the validation testing would not be further reduced by modifications of design of the user interface (including any accessories and the IFU), is not needed, and is outweighed by the benefits that may be derived from the device’s use.

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Support for Appropriate Application of Human Factors Methods to Medical Device Design

Quality System / Design Control Regulations

Medical device manufacturers are required to comply with the Quality System regulation, 21 CFR Part 820. In particular, Section 30, Design Controls, includes requirements relevant to human factors.

FDA-Recognized Standards

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.

FDA – Guidance Documents on Human Factors

FDA has developed several guidance documents to support device manufacturers to apply appropriate human factors methods in the design of their products.

FDA – Guidance and Information on Medical Device Labeling

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Resources on Human Factors Considerations for Specific User Populations

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Page Last Updated: 06/30/2014
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