[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Pages 951-953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00003]



Food and Drug Administration

[Docket No. FDA-2012-N-1205]

Accessible Medical Device Labeling in a Standard Content and 
Format Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Accessible Standardized Medical 
Device Labeling.'' The purpose of this public workshop is to discuss 
the growing need for medical device labeling to be delivered in a 
clear, concise, and readily accessible format so that patients, 
caregivers, and healthcare providers may access and utilize device 
labeling as efficiently and effectively as possible. This public 
workshop aims to engage stakeholders in active discussion with FDA and 
to encourage public comments regarding standard content and format for 
medical device labeling and the use of a repository containing medical 
device labeling.

DATES: The public workshop will be held on April 29, 2013, from 8 a.m. 
to 5 p.m. and April 30, 2013, from 8 a.m. to 4 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the 
public meeting participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Mary Weick-Brady, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5426, 301-796-6089, FAX: 301-847-8510, 
email: Mary.Brady@fda.hhs.gov.

    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by April 5, 2013. 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 day of the public workshop 
will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Joyce Raines by email: Joyce.Raines@fda.hhs.gov or phone: 301-
796-5709 at least 7 days prior to the public workshop.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & 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, address, email, and telephone number. Those without 
Internet access should contact Mary Weick-Brady to register (see FOR 
FURTHER INFORMATION CONTACT). 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 April 5, 2013, 5 p.m. EST. 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 April 5, 2013. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. 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.
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration, you may indicate if you wish to present during a public 
comment session and which topics you want to address. All topic-focused 
sessions will be held

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during the general session. Standard content and format of full 
labeling and a shortened version of labeling will be addressed on the 
first day. The labeling repository will be discussed in a focused 
session on the second day. FDA has included general topics in this 
document. FDA will do its best to accommodate requests to make public 
comments. Individuals and organizations with common interests are urged 
to consolidate or coordinate their presentations, and request time for 
a joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by April 12, 2013. All requests 
to make oral presentations must be received by the close of 
registration on April 5, 2013, at 5 p.m. If selected for presentation, 
any presentation materials must be emailed to Mary Weick-Brady (see FOR 
FURTHER INFORMATION CONTACT) no later than March 29, 2013. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    Comments: FDA is holding this public workshop to obtain information 
on medical device 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 
topics. The deadline for submitting comments related to this public 
workshop is April 12, 2013.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments to http://www.regulations.gov or 
written comments regarding this document 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 
questions as outlined in section II of this document, please identify 
the question 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. It may 
be viewed at the Division of Dockets Management (see Comments). 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 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

I. Background

    Currently, there are no regulations that explicitly define and 
describe a standard content and format for medical device labeling. FDA 
is concerned that the lack of standard content and format may translate 
into an increased risk of medical device error. Also, there is no 
single available source of medical device labeling for people to view, 
search, and download for devices that are used in clinical and non-
clinical environments. FDA is aware of and concerned with the risk of 
medical errors that result from lost or inaccessible labeling.
    FDA conducted a two-phase research study with Research Triangle 
Institute (RTI) focusing on healthcare professionals and their 
experiences with medical device labeling, and what they would want in a 
standard version of device labeling. Key findings from the survey 
helped create an outline for standard content and format for medical 
device labeling identifying the most relevant sections. Participants 
also expressed the need for a condensed version of labeling to act as a 
quick reference for safe and effective use of devices. Participants 
indicated that having a ``quick guide'' describing proper device 
operation and use would be more convenient and effective with the 
option of referring to a more comprehensive form of labeling should it 
be required.
    FDA also conducted a survey with the National Family Caregivers 
Association (NFCA) on medical device labeling to elicit home 
caregivers' experiences with medical device labeling for devices that 
are used in the home. Respondents indicated what sections of medical 
device labeling they believed would be most important when operating or 
troubleshooting a device in the home care environment. Respondents also 
stated they would like a standard content and format of labeling with 
access to a ``quick guide'' for proper instructions for use. The 
majority of respondents stated they would make use of a searchable Web 
site that contained labeling for medical devices.
    Accessible labeling has been a growing problem for healthcare 
professionals who operate medical devices, lay caregivers, and patients 
themselves. As more medical devices migrate out of clinical care 
environments and into patients' homes, the assurance that devices are 
being used properly and safely no longer resides with a healthcare 
professional; rather, the responsibility is with the patient, spouse, 
sibling, or even children. When medical devices are sent home with 
patients or are moved from one location to another, the labeling often 
becomes misplaced, lost, damaged, or discarded, which may result in 
adverse events or other complications due to misinterpretations and 
absence of proper labeling.
    FDA is holding this public workshop to address these growing 
concerns and to solicit responses from the medical devices industry, 
healthcare practitioners, caregivers, and patients regarding a standard 
content and format of medical device labeling and methods to make 
medical device labeling accessible and searchable while keeping patient 
safety a priority.

II. Topics for Discussion at the Public Workshop

    The workshop sessions will focus on the following general topics:

A. Summary of FDA Work on Labeling

    1. RTI two-phase research study of healthcare professionals 
regarding device labeling.
    2. NFCA survey of consumers on medical device labeling.
    3. Cooperative Research and Development Agreement with Kwikpoint 
for the development of visual language for device labeling.
    4. The Center for Drug Evaluation and Research measures of success 
with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

    1. Review the outline for a draft standard content and format of 
medical device labeling.
    2. Current thinking on a standard content and format of medical 
device labeling.
    3. Use of symbols in medical device labeling.
    4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

    1. Online access to device labeling.

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    2. Panel discussions on using an online device labeling site.
    3. Discuss the types of devices whose labeling should be on the 

    Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00003 Filed 1-4-13; 8:45 am]