> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Human Factors Subsmissions
- URL: https://www.fdaweb.com/draft-guide-on-human-factors-subsmissions/
- Published: 2018-09-28T12:00:00.000Z
- Updated: 2026-09-15T00:34:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142470

FDA has issued a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM621902.pdf?ref=fdaweb.com) entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Application.” The document provides recommendations on the contents of such submissions, and presents timelines for their review. It says that a comprehensive use-related risk analysis may be a separate submission or may be included as part of another submission (e.g. with a human factors validation study protocol or human factors engineering report. The guide also recommends the contents of a risk analysis.