Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their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 This guidance revises and replaces the draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” issued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 This revised draft guidance is not final nor is it in effect at this time.
Scope & Applicability
Product Classes
8Guidance topic regarding classification categories
Drug A, an animal drug indicated for the treatment and prevention of flea infestation
Drug X, a prescription drug indicated to treat acne vulgaris; Addressing misinformation about medical devices and prescription drugs
Medical devices intended for human use; Approved or cleared medical devices
Human prescription drugs including biological products
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Includes biological products
Regulated medical product
Stakeholders
5Entities initiating communications regarding medical products; Applicants, sponsors, manufacturers, packers, and distributors; The entity (manufacturer/distributor) sharing information about medical products; Entities disseminating scientific information on unapproved uses; Entity responsible for generating and disseminating SIUU communications; entity generating presentations regarding medical products
Used to convey firm messages in internet-based settings.
Entities that create or disseminate misinformation; Entity not acting on behalf of the firm; misinformation created or disseminated by an independent third party; A content creator on a social media platform, who is an independent third party
HCPs engaged in prescribing or administering medical products; Recipients of SIUU communications; Target audience for SIUU communications; audience for SIUU communications and clinical decision makers
inform patients and HCPs about the benefits and safety of biosimilars
Regulatory Context
Attributes
3Prescribing Information for Drug X includes a boxed warning
Uses of a medical product not approved or cleared by the FDA.
Drug X is contraindicated during pregnancy
Identified Hazards
Hazards
4Misinformation about medical products treating serious diseases
Device Y increases the risk of severe, life-threatening vascular injuries
Prescribing Information for Drug X includes a boxed warning about embryo-fetal toxicity
False, inaccurate, or misleading representations of fact
Related CFR Sections (14)
- 21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
- 21CFR201.105§ 201.105 Veterinary drugs.
A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1) ) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161 , or if all tRead full regulation →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR314.98§ 314.98 Postmarketing reports.
(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR1.21§ 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR314.550§ 314.550 Promotional materials.
For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, inteRead full regulation →
- 21CFR601.45§ 601.45 Promotional materials.
For biological products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisementsRead full regulation →
- 21CFR314.640§ 314.640 Promotional materials.
For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, inteRead full regulation →
- 21CFR601.94§ 601.94 Promotional materials.
For biological products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisementsRead full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
Related Warning Letters (1)
- 2025-09-16
False & Misleading Claims/Misbranded
Aytu Biopharma
See Also (8)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Status: Draft)
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)