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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/addressing-misinformation-about-medical-devices-and-prescription-drugs-questions-and-answers?utm_medium=email&utm_source=govdelivery Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe the agency’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products. This revised draft guidance would apply only to approved/cleared medical products, which include medical devices for human use (including biological products), prescription human drugs (including biological products), and prescription animal drugs. This document revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued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 guidance will help the public get the accurate, up-to-date, science-based information they need to inform their decisions about medical products to maintain and improve their health.Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe the agency’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products. This revised draft guidance would apply only to approved/cleared medical products, which include medical devices for human use (including biological products), prescription human drugs (including biological products), and prescription animal drugs. This document revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued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 guidance will help the public get the accurate, up-to-date, science-based information they need to inform their decisions about medical products to maintain and improve their health.