[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Pages 43093-43095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17800]



Food and Drug Administration

[Docket No. FDA-2000-D-0067]

Medical Device Patient Labeling; Request for Comments; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration is announcing the following 
public workshop entitled ``Medical Device Patient Labeling''. The 
purpose of the public workshop is to discuss issues associated with the 
development and use of medical device

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patient labeling including content, testing, use, access, human 
factors, emerging media formats, and promotion and advertising. The 
Center for Devices and Radiological Health (CDRH) is seeking input into 
these topics from patients and advocacy groups, academic and 
professional organizations, industry, standards organizations, and 
governmental Agencies. Ideas generated during this workshop will help 
facilitate development or revision of guidances and/or standards for 
medical device patient labeling.
    Date and Time: The workshop will be held on September 29, 2015, 
from 8 a.m. to 5 p.m. and September 30, 2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
    Contact Person: Antoinette (Tosia) Hazlett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-796-6119, 
[email protected] gov.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending the ``Medical 
Device Patient Labeling'' public workshop must register online by 4 
p.m. on September 21, 2015. Early registration is recommended because 
facilities are limited and, therefore, FDA may limit the number of 
participants from each organization. If time and space permit, onsite 
registration on the days of the public workshop will be provided 
beginning at 7 a.m. If you need special accommodations due to a 
disability, please contact Susan Monahan at least 7 days in advance of 
the meeting.
    To register for the public workshop, please visit CDRH's Workshops 
and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public 
workshop from the posted events list.) Please provide complete contact 
information for each attendee, including name, title, affiliation, 
email, and telephone number. Those without Internet access should 
contact Susan Monahan to register (see Contact Person). Registrants 
will receive confirmation after they have been accepted. You will be 
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 4 p.m. on September 21, 2015. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after September 25, 2015. If you have never attended 
a Connect Pro event before, test your connections at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. (FDA has 
verified the Web site addresses in this document, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    Comments: FDA is holding this public workshop to obtain stakeholder 
input on medical device patient labeling. In order to permit the widest 
possible opportunity to obtain public comment, FDA is soliciting either 
electronic or written comments on all aspects of the public workshop. 
The deadline for submitting comments regarding this public workshop is 
October 30, 2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
topics as outlined in ``Topics for Discussion'', please identify the 
topic you are addressing. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at: http://www.regulations.gov. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at: 


I. Background

    The CDRH Guidance on Medical Device Patient Labeling (available at 
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070782.htm) serves to assist manufacturers in 
their development of patient labeling and to assist Center reviewers in 
their review and evaluation of the manufacturers' labeling. Medical 
device patient labeling includes any medical device information that is 
intended for a lay audience. It is intended to help assure that the 
device is used safely and effectively. This labeling may pertain to 
therapeutic, restorative, diagnostic, or cosmetic devices. Medical 
device patient labeling is supplied in many formats, for example: As 
patient brochures, patient leaflets, user manuals, videos or audio 
recording, and through physical or online media. This labeling is 
intended to be supplied to or available to patients or their lay 
caregivers for their use with or without accompanying professional 
counseling. While some patients receive labeling from their healthcare 
practitioners or device suppliers, others receive it in the packaging 
of over-the-counter devices. CDRH is collecting public comment to use 
in updating the Medical Device Patient Labeling Guidance.
    FDA is committed to supporting the development and availability of 
patient labeling which supports the safe and effective use of medical 
devices by patients. To inform FDA in their efforts, they are seeking 
input on the topics identified in section II.

II. Topics for Discussion

    FDA seeks to address and receive comments on the following topics:

A. Current Medical Device Patient Labeling

    (1) The current use and practice trends of medical device patient 
labeling development and use. For example: When is medical device 
patient labeling used? How much medical device patient labeling exists? 
How much modification and revision of existing medical device patient 

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occurs, and under what circumstances? What is the role of voluntary 
consensus standards in developing medical device patient labeling?
    (2) What risks or adverse outcomes have been reported in 
association with the use of medical device patient labeling? What 
communication barriers have been encountered, and how can they be 
    (3) Is there any part of the medical device patient labeling 
development process that presents a barrier to receiving approval or 
clearance from CDRH? If so, please provide examples of the specific 
issues, how frequently this occurs, and suggestions which 
constructively address these barriers.
    (4) What are the best ways to foster efficient networking with 
patients and advocacy groups, academic and professional organizations, 
industry, standards organizations, and government Agencies to address 
medical device patient labeling needs?

B. Medical Device Patient Labeling Needs Assessment

    (1) Describe the parameters that should be used in determining 
priority areas of development of medical device patient labeling, 
including both therapeutic and diagnostic devices.
    (2) What are best practices for conducting a needs assessment of 
medical device patient labeling?

C. Advancing Development

    (1) What could advance the development and use of medical device 
patient labeling?
    (2) How should patient labeling be considered in the development 
stages of all medical device labeling?
    (3) What resources (e.g., registries, industry, or patient advocacy 
groups,) could be tapped to advance the development of medical device 
patient labeling?
    (4) What are potential changes to guidances and regulations, or 
advances in current science that may help develop and enhance medical 
device patient labeling to address the needs of medical device 
manufacturers, device suppliers, and device users?

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17800 Filed 7-20-15; 8:45 am]