Draft Guidance on Human Factors and Usability Engineering Issued by FDA

The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.

The guidance is intended to improve device usability and reduce usage errors, injuries and recalls in order to control and mitigate risks stemming from medical device use. Recommendations for optimized device design focus on analysis, testing and validation of human factors in order to improve user interfaces and reduce likelihood of user errors.

If a manufacturer’s analysis of risks associated with use of its device indicate moderate to high likelihood of user error, or if a marketed device is undergoing modification to correct a problem associated with its use, the guidance document recommends that the manufacturer conduct human factors testing. FDA officials may also request such testing if any of the following factors apply:

  1. Submitting human factors data is required as a special control
  2. Human factors information is recommended in a specific guidance for a particular device type
  3. Such data is needed on a for-cause basis if it can efficiently address FDA concerns regarding human factor issues

If any of the scenarios described above are pertinent, the guidance suggests that a manufacturer include a summary of human factors processes, evaluations and validation testing results in its pre-market application.

Interested parties have 90 days to submit comments on the draft guidance. Upon finalization, the guidance will replace the document Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, which went into effect in July 2000.

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