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GUIDANCE DOCUMENT

Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle October 2026

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document provides technical specifications for submitting data from a clinical trial to evaluate the ability to operate a motor vehicle (herein referred to as a driving study) to support a marketing application for drug or biological product. As presented in FDA’s guidance for industry Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (November 2017), driving studies are primarily conducted to evaluate the effects of psychoactive drugs on the ability to operate a motor vehicle, though driving studies can also be conducted to evaluate effects of certain non-psychoactive drugs.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821.

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