> ## 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 Submissions
- URL: https://www.fdaweb.com/draft-guide-on-human-factors-submissions/
- Published: 2018-10-01T12:00:00.000Z
- Updated: 2026-09-15T00:35:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142482

*Federal Register* notice: FDA has made available a draft guidance entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.” The document provides recommendations on the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use human factors study protocols and reports. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-01/pdf/2018-21243.pdf?ref=fdaweb.com).