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GUIDANCE DOCUMENT

Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers July 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2014-D-0447
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Addressing Misinformation About Medical Devices and Prescription Drugs:  Questions and Answers.” This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” issued in June 2014. This revised draft guidance is not final nor is it in effect at this time. 

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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-2014-D-0447.

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