Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments, 951-953 [2013-00003]
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<![CDATA[
951
Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2012, THROUGH SEPTEMBER 30, 2012—Continued
PMA No., Docket No.
Applicant
Trade name
P080030, FDA–2012–M–
0712.
P110007, FDA–2012–M–
0734.
P110037, FDA–2012–M–
0713.
P110030, FDA–2012–M–
0735.
P110043, FDA–2012–M–
0833.
P040024/S056, FDA–2012–
M–0968.
P110006, FDA–2012–M–
1011.
Glaukos Corp ....................
Glaukos iStent® Trabecular Micro-Bypass Stent and
Inserter.
Healon® EndoCoat OpViscosurgical Ophthalmic Device (OVD) (3% Sodium Hyaluronate).
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test ....
June 25, 2012.
therascreen® KRAS RGQ PCR Kit ...............................
July 6, 2012.
Omnilink Elite Vascular Balloon-Expandable Stent
System.
Restylane L Injectable Gel ............................................
July 31, 2012.
Abbott Medical Optics, Inc
Roche Molecular Systems,
Inc.
QIAGEN Manchester, Ltd
Abbott Vascular .................
Medicis Aesthetics Holdings, Inc.
U-Systems, Inc ..................
II. Electronic Access
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–00004 Filed 1–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
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.
wreier-aviles on DSK7SPTVN1PROD with
SUMMARY:
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Breast
Ultrasound
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 https://
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.
SUPPLEMENTARY INFORMATION:
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 &
DATES:
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
AGENCY:
somo-v® Automated
(ABUS).
Approval date
PO 00000
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System
July 2, 2012.
July 5, 2012.
August 30, 2012.
September 18, 2012
Conferences calendar at https://
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 https://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
E:\FR\FM\07JAN1.SGM
07JAN1
wreier-aviles on DSK7SPTVN1PROD with
952
Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
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
https://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 https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
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(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 https://
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
PO 00000
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Sfmt 4703
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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Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
2. Panel discussions on using an
online device labeling site.
3. Discuss the types of devices whose
labeling should be on the site.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–00003 Filed 1–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
ACTION:
Notice.
Summary: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
Bureau of Health Professions (BHPr)
Performance Data Collection (OMB No.
0915–0061)—Revision
Abstract: Over 40 BHPr programs
award grants to health professions
schools and training programs across
the United States to develop, expand,
and enhance training, and to strengthen
the distribution of the health workforce.
Many of these programs are governed by
the Public Health Service Act (42 U.S.C.
201 et seq.), specifically Titles III, VII,
and VIII. Performance information is
collected in the HRSA Performance
Report for Grants and Cooperative
Agreements (PRGCA). Data collection
activities at application, progress, and
annual performance satisfy statutory
and programmatic requirements for
performance measurement and
evaluation (including specific Title III,
VII, and VIII requirements), as well as
Government Performance and Results
Act (GPRA) requirements. The
Affordable Care Act impacted a broad
range of health workforce programs
administered by BHPr. It reauthorized
many of these programs and, in some
cases, expanded eligibility, modified
program activities, and/or established
new requirements. The Affordable Care
Act also created new health professions
programs. Therefore, it was necessary to
reexamine BHPr’s existing performance
measures to ensure that they address
these changes, meet evolving program
management needs, and respond to
emerging workforce concerns.
The purpose of the proposed revised
data collection is to enhance analysis
and reporting of grantee training
activities and education, identify
intended practice locations, and report
outcomes of funded initiatives. Data
collected from these grant programs will
Number of
respondents
Form name
Number of
responses per
respondent
also provide a description of the
program activities of more than 1,600
reporting grantees to better inform
policymakers on the barriers,
opportunities, and outcomes involved
in health care workforce development.
The proposed measures focus on five
key outcomes: (1) Increasing the
workforce supply of diverse welleducated practitioners, (2) influencing
the distribution of practitioners to
practice in underserved and rural areas,
(3) enhancing the quality of education,
(4) diversifying the pipeline for new
health professionals, and (5) supporting
educational infrastructure to increase
the capacity to train more health
professionals.
Revisions to the current reporting will
require the collection of baseline data at
the grant application and award stages
and will include improved performance
reporting at three levels of
measurement: individual-level,
program-specific, and program clusterlevel.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Application ............................................................................
Program Aggregate Data Collection * .................................
Individual-level Data Collection ............................................
2,500
500
800
1
1
1
2,500
500
800
8
10
5
20,000
5,000
4,000
Total ..............................................................................
........................
........................
........................
........................
29,000
wreier-aviles on DSK7SPTVN1PROD with
* Program aggregate data collection will only be required for programs that do not provide direct financial support to students.
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]]>Agencies
[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Pages 951-953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 https://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.
SUPPLEMENTARY INFORMATION:
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 https://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 https://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
[[Page 952]]
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 https://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 https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://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
https://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.
[[Page 953]]
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the
site.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00003 Filed 1-4-13; 8:45 am]
BILLING CODE 4160-01-P
