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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 5-57
ANSI AAMI  HE75:2009/(R)2018
Human factors engineering - Design of medical devices
1.1 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 emphas 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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 9 (Usability testing) is not recognized.
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:

Section 9 (Usability testing) is in conflict with existing published final guidance. See Section 8: Human Factors Validation Testing in guidance listed below.
Relevant FDA Guidance and/or Supportive Publications*
Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff. Document issued on: February 3, 2016.

AAMI TIR50:2014 Post-market surveillance of use error management

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Tania Reina
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.