4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0447]
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions
and Answers; Draft Guidance for Industry; Availability; Agency Information Collection
Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: 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availability of a revised draft guidance for industry entitled “Addressing Misinformation About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 This revised draft guidance,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 This guidance revises and replaces the draft guidance for industry entitled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 This revised draft guidance is not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.
DATES: Submit either electronic or written comments on the draft guidance by [INSERT
DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] to ensure
that the Agency considers your comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the proposed collection of
information in the draft guidance by [INSERT DATE 60 DAYS AFTER DATE OF THE
PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: You may submit comments on any guidance at any time as follows:
Electronic Submissions

Submit electronic comments in the following way:
•

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for
submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov will be posted to the docket unchanged. Because your
comment will be made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else’s Social Security number, or
confidential business information, such as a manufacturing process. Please note that if
you include your name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on
https://www.regulations.gov.

•

If you want to submit a comment with confidential information that you do not wish to be
made available to the public, submit the comment as a written/paper submission and in
the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
•

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

•

For written/paper comments submitted to the Dockets Management Staff, FDA will post
your comment, as well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2014-D-0447

for “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and
Answers.” Received comments will be placed in the docket and, except for those submitted as

“Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
•

Confidential Submissions--To submit a comment with confidential information that you
do not wish to be made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states “THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy,
including the claimed confidential information, in its consideration of comments. The
second copy, which will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this information as
“confidential.” Any information marked as “confidential” will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA’s posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and

written/paper comments received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the “Search” box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug
Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001

New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the Office
of Communication, Outreach and Development, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,
MD 20993-0002; the Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD
20993-0002; or the Policy and Regulations Staff, Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed
adhesive label to assist that office in processing your request or include a Fax number to which
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: Samantha
Bryant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Room 3203, Silver Spring, MD 20993-0002, 301-796-1200; James
Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Stephanie
Philbin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-837-7151; Kathryn
Dennehy, Center for Veterinary Medicine (HFV-245), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-7082, Kathryn.Dennehy@fda.hhs.gov; or Julie
Finegan, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-827-4830.
With regard to the proposed collection of information: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background

FDA is announcing the availability of a revised draft guidance for industry entitled
“Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and
Answers.” In addition to describing already existing avenues for communications by firms, the
guidance sets out an enforcement policy for certain kinds of internet-based communications that
firms might choose to use to address internet-based misinformation about or related to the firm’s
approved/cleared medical product when that misinformation is created or disseminated by an
independent third party. This guidance is not intended to address a firm’s correction of its own
false or misleading representations about its medical products. For the purposes of this guidance,
the term firms refers to the persons or entities legally responsible for the labeling of
approved/cleared medical products, which includes applicants, sponsors, manufacturers, packers,
distributors, and any persons communicating on behalf of these entities. The term medical
product refers to a medical device for human use (including one that is a biological product), a
prescription human drug (including one that is a biological product), or a prescription animal
drug. The term approved/cleared medical product refers to medical products (as that term is
defined in this guidance) that may be introduced into interstate commerce for at least one use
under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act,
and their implementing regulations (collectively, the FDA Authorities) as a result of having
satisfied applicable premarket requirements. For ease of reference, when approval and clearance
(and similar terms) are used in discussing devices, the terms refer to FDA permitting the
marketing of a device via the premarket approval, premarket notification under section 510(k) of
the FD&C Act (21 U.S.C. 360(k)), De Novo classification, or Humanitarian Device Exemption
pathways and to devices that are exempt from premarket notification.
For the purposes of this guidance and as further described in section II of the guidance,
the term misinformation refers to implicit or explicit false, inaccurate, or misleading
representations of fact about or related to the firm’s approved/cleared medical product.

Misinformation about a firm’s approved/cleared medical product can cause harm to both
individuals and the public health in general. Basing medical decisions on misinformation can
lead patients and healthcare providers to choose treatments that are not safe and effective, or
forgo treatments that are, which can have adverse consequences. While misinformation can
appear in many forms of communication and be shared in many different ways, internet-based
forms of communication have enabled misinformation to travel quickly and reach more people
who otherwise might not be exposed to that misinformation. Additionally, misinformation about
or related to medical products that treat or prevent serious or life-threatening diseases is
especially concerning and represents a significant public health concern.
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 (2014 draft guidance). The
revised draft guidance reflects the Agency’s consideration of feedback from interested parties,
including comments received on the 2014 draft guidance. Changes include a revised title, a
question-and-answer format, and certain changes in scope. For example, the enforcement policy
now extends to a firm’s voluntary “tailored responsive communications” that address
misinformation that suggests that the firm’s cleared/approved medical product be used for an
unapproved use. Additionally, new content has been added to reflect changes in technology and
functionality of internet-based platforms, as well as changes in the way information is shared
online to help a firm to have greater flexibility and control over the timing of the firm’s
communication when the firm chooses to address certain internet-based third-party
misinformation with “tailored responsive communications.” This guidance also now includes a
subsection on “general medical product communications” that describes many existing avenues
available to firms for communicating information about or related to their approved/cleared
medical products. New examples were also added to illustrate the new considerations and
recommendations outlined in the guidance and to provide additional clarity to firms.

This revised draft guidance, when finalized, is intended to advance FDA’s mission to
help members of 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. More
specifically, the guidance describes two categories of communications firms might choose to use
to address misinformation: tailored responsive communications and general medical product
communications.
As described in the guidance, a “tailored responsive communication” is a firm’s
voluntary, internet-based communication that identifies and addresses internet-based
misinformation about or related to the firm’s approved/cleared medical product when that
misinformation is created or disseminated by an independent third party.
For the purposes of this guidance, communications through existing avenues are
collectively referred to as “general medical product communications.” Unlike the tailored
responsive communications described in the guidance, general medical product communications
are not necessarily internet-based or prompted by or tailored to address specific identified
internet-based misinformation. General medical product communications can include, among
other things, content and messaging that address misinformation about a firm’s approved/cleared
medical product. Inclusion in a general medical product communication of content that
addresses misinformation creates no special considerations regarding the application of the FDA
Authorities or other FDA enforcement policies.
FDA recognizes that misinformation about or related to medical products authorized for
emergency use is a public health concern. The Agency continues to evaluate the unique
considerations that can apply to communications by firms addressing misinformation about or
related to such products. As such, this revised draft guidance does not apply to communications
by firms that address misinformation about or related to an emergency use authorized for the
firm’s medical product under section 564 of the FD&C Act (21 U.S.C. 360bbb-3), whether that
be an emergency use authorized for an “unapproved use of an approved product”, or an

emergency use authorized for an “unapproved product”, as those terms are used in section 564(a)
of the FD&C Act. See section 564 of the FD&C Act for more information on the authorities for
emergency use authorizations.
This revised draft guidance is being issued consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent
the current thinking of FDA on “Addressing Misinformation About Medical Devices and
Prescription Drugs: Questions and Answers.” It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. “Collection of information” is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of information set forth in this
document.
With respect to the following collection of information, FDA invites comments on these
topics: (1) whether the proposed collection of information is necessary for the proper
performance of FDA’s functions, including whether the information will have practical utility;
(2) the accuracy of FDA’s estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information technology.
Disclosures For Tailored Responsive Communications Addressing Misinformation About
Medical Devices and Prescription Drugs
OMB Control Number 0910-NEW
The revised draft guidance document, “Addressing Misinformation About Medical
Devices and Prescription Drugs: Questions and Answers,” describes two categories of
communications firms might choose to use to address misinformation: tailored responsive
communications and general medical product communications. As explained in the guidance,
general medical product communications are already existing avenues for communication and
are subject to approved information collections, summarized below. The revised draft guidance
recommends that a firm’s tailored responsive communication clearly identify both the specific
misinformation that the firm is addressing and a specific internet-based, independent third-party
communication in which that misinformation appears. Additionally, the revised draft guidance
discusses disclosures that we recommend firms include when choosing to share tailored
responsive communications.
Specifically, the guidance recommends that firms include (1) a mechanism for obtaining
a copy of the current FDA-required labeling (including FDA-approved patient labeling, if any),
(2) the date the firm’s tailored responsive communication is posted (if a date is not automatically
generated), and (3) a disclosure that the tailored responsive communication is being shared by
the medical product firm or that the person addressing the misinformation is affiliated with the
firm and is authorized to provide information on behalf of the firm about the medical product.
The guidance also provides recommendations for firms that wish to use a tailored responsive
communication to address misinformation about or related to an unapproved use of the firm’s
approved/cleared medical product. Specifically, the guidance recommends including an
additional disclosure identifying the unapproved use and noting that the unapproved use of the

medical product has not been approved by FDA and that the safety and effectiveness of the
medical product for the unapproved use has not been established.
We estimate the burden of the information collection as follows:
Table 1.--Estimated Annual Third-Party Disclosure Burden1
Recommended Disclosure
No. of
No. of
Total Annual
Activity; Guidance Section
Respondents
Disclosures per
Disclosures
Respondent

Average
Burden
per
Disclosure
0.4 (24
minutes)

Total
Hours

Clearly identify both the specific
958
50
47,900
19,160
misinformation that the firm is
addressing and a specific internetbased, independent third-party
communication in which that
misinformation appears; Section
IV.A. Q3
A mechanism for obtaining a copy
958
50
47,900
0.1 (6
4,790
of the current FDA-required
minutes)
labeling (including FDA-approved
patient labeling, if any); Section
IV.A. Q5
The date the firm’s tailored
958
50
47,900
0.05 (3
2,395
responsive communication is
minutes)
posted (if a date is not
automatically generated); Section
IV.A. Q5
A disclosure that the tailored
958
50
47,900
0.1 (6
4,790
responsive communication is
minutes)
being shared by the medical
product firm or that the person
addressing the misinformation is
affiliated with the firm and is
authorized to provide information
on behalf of the firm about the
medical product; Section IV.A. Q5
In the case of a tailored responsive
958
5
4,790
0.1 (6
479
communication that addresses
minutes)
misinformation about an
unapproved use of the firm’s
approved/cleared medical product,
a disclosure identifying the
unapproved use and noting that the
unapproved use of the medical
product has not been approved by
FDA and that the safety and
effectiveness of the medical
product for the unapproved use
has not been established; Section
IV.A. Q5
Total
196,390
31,614
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on data currently available to FDA on the number of firms disseminating
promotional communications about prescription drugs (697) combined with an estimated number
of device firms marketing products (261), we assume that approximately 958 firms (“number of

respondents” in table 1) might each choose to disseminate 50 tailored responsive
communications annually. Our estimate of the burden per disclosure reflects what we believe is
the average burden based on the number and content and complexity of disclosures as
recommended in the guidance.
This draft guidance also refers to previously approved FDA collections of information.
The collections of information in 21 CFR part 314 are approved under OMB control number
0910-0001. The collections of information in 21 CFR part 201 regarding content and format of
labeling for human drug and biological products are approved under OMB control number 09100572. The collections of information in 21 CFR part 801 are approved under OMB control
number 0910-0485. The collections of information in 21 CFR 202.1 regarding prescription drug
advertising are approved under OMB control number 0910-0686. The collections of information
in 21 CFR part 601 regarding marketing approval of biological products are approved under
OMB control number 0910-0338; and the collections of information regarding marketing
approval of animal drug products in 21 CFR part 514 are approved under OMB control number
0910-0032.
III. Electronic Access
Persons with access to the internet may obtain an electronic version of the draft guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/biologics-guidances,
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.h
tm, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: July 3, 2024.
Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2024-15009 Filed: 7/8/2024 8:45 am; Publication Date: 7/9/2024]