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Recognized Consensus Standards
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Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 5-57: AAMI / ANSI HE75:2009, Human factors engineering - Design of medical devices. (General)

Date of Standard: 2010. 
Addresses of Standards Organizations:
  Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
  American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division Associated with Recognized Standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
All Medical Devices
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality Systems Regulation-Design Controls
Type of Standard:
 Horizontal, International
Extent of Recognition:
This standard serves as a guideline for integrating human factors engineering into the product design and development process necessary to satisfy the FDA Quality Systems-Design Control requirement to ensure that the needs of the user are appropriately defined, verified and validated.

Any declaration of conformance to this standard with respect to the design and development of any particular medical device should be accompanied by the following documentation at a minimum:

1. A functional description and pictorial representation of the device-user interface.
2. Instructions for use.
3. Description of the intended user populations, operating conditions, and a comprehensive description of user tasks. A description of potential use-related hazards and risk estimation including reasonably foreseeable use errors relevant to user's interaction with the device, user interface and a summary of the process applied for this purpose.
4. A summary description of preliminary and iterative evaluation and modification of the user interface with respect to user needs for safety and effectiveness of its use.
5. A summary of validation of device use study or studies that focuses on user tasks with respect to risk of inadvertent harm or mistreatment, and containing both objective (performance) assessment as well as comprehensive subjective assessment by study participants with respect to the safety and usability of key aspects of device use, and the capability to detect and describe the nature and potential risk of all performance failures including unanticipated failure modes and subsequent validation, as necessary, of any mitigations for failures detected during the validation.
Related CFR Citations and Product Codes:
 
Relevant Guidance:
For additional guidance on human factors engineering as it relates to the incorporation of human factors engineering techniques into risk management process consistent with the Quality System Regulation-Design Controls, see CDRH guidance "Medical Device Use Safety: Incorporating Human Factors into Risk Management" available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094461.pdf

It is noteworthy that human factors engineering is commonly referenced in other guidance documents. The information provided in the CDRH guidance list above, is intended to clarify the human factors portion of the document referencing medical device human factors.
FDA Technical Contact:
  Ron D. Kaye
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2520
  Silver Spring MD 20993
  301/796-6289
  Email: ron.kaye@fda.hhs.gov
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