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Oct 21, 2009. Provides detailed human factors engineering (HFE) design guidance to those who are responsible for HFE work within medical device companies. It contains extensive design guidance, examples, checklists, and case studies. Product Details. Published:; ISBN(s)::; ANSI: ANSI. ![]() General This recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error. The presumed users of this document are human factors and usability specialists, software developers, industrial, biomedical, mechanical, and electrical engineers, and other development personnel. Other users might include clinicians, clinical and biomedical engineers, and others who evaluate devices before purchase or after use errors have occurred, regulatory agencies, purchasing entities, and others interested in assessing the usability of medical devices. Inclusions This recommended practice covers general HFE principles, specific HFE principles geared towards certain userinterface attributes, and special applications of HFE (e.g., hand tool design).
• • • • • • • • • • • • • • • • 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 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. HFE/UE Validation Report Contained in a Premarket Application or Submission A Human Factors Engineering or Usability Engineering (HFE/UE) report included in a premarket submission should provide information pertaining to device use safety and effectiveness in summary form. The report should discuss the safety-related HFE/UE considerations, issues, processes, resolutions, and conclusions. The level of detail of documentation submitted should be sufficient to describe your identification, evaluation, and final assessment of all serious use-related hazards for the device. To facilitate FDA review, materials used directly in the HF/UE process, including portions of risk analyses focusing on user interactions with the device and specific risk analysis processes, results and conclusions should be included in the HFE/UE report. A recommended structure for the HFE/UE report, which will support efficient FDA review of these materials, is listed and described in the table below. 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