top of page

USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers”. Once finalized, this guidance will outline the FDA's current thinking on common questions companies may have when voluntarily responding to misinformation regarding their approved/cleared medical products.

Misinformation refers to implicit or explicit false, inaccurate, or misleading representations of facts about or related to the firm’s approved/cleared medical product.

This guidance addresses common questions firms may have about voluntarily correcting misinformation related to their approved or cleared medical products. It outlines existing communication avenues and sets an enforcement policy for certain internet-based communications that firms might use to address misinformation spread by independent third parties. The recommendations and examples aim to support firms in addressing misinformation about their medical products.

Medical products that are approved/cleared have met applicable premarket requirements and can be introduced into interstate commerce for at least one application under the FDA Authority. The enforcement policy in this guidance applies when a firm voluntarily shares an internet-based communication to identify and address misinformation that is:

  • About or related to the firm’s approved or cleared medical product,

  • In Internet-based communication, and

  • Created or disseminated by an independent third party.

Following the FDA's guidance, stakeholders can effectively manage and correct misinformation, ensuring that the public can access accurate and reliable information. There are examples included in this guidance to illustrate some of the general recommendations and considerations outlined in the document. The examples are provided for illustrative purposes only.


bottom of page