[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14028-14030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5950]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0122]
Center for Devices and Radiological Health 510(k) Implementation:
Online Repository of Medical Device Labeling, Including Photographs;
Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``510(k) Implementation: Discussion of an Online
Repository of Medical Device Labeling and of Making Device Photographs
Available in a Public Database Without Disclosing Proprietary
Information.'' The purpose of the meeting is to obtain public comment
on the following topics: FDA's plans to establish an online public
repository of medical device labeling and strategies for displaying
device photographs in a public database without disclosing proprietary
information.
DATES: Date and Time: The public meeting will be held on April 7,
2011, from 8:30 a.m. to 5 p.m.
Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD
20903.
Contact Person: Joyce Siwarski, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5402, Silver Spring, MD 20903,
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301-796-5422, FAX: 301-847-8510, e-mail: Joyce.Siwarski@fda.hhs.gov.
Registration and Requests for Oral Presentations: Online
registration is available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm243829.htm. Required registration
information includes name, title, firm name, address, e-mail,
telephone, and fax number, if available. Space is limited, so online
registration will close at 5 p.m. on March 31, 2011. You will be
notified if you are on a waiting list. If registration is not filled,
onsite registration may become available.
If you wish to make an oral presentation during any of the open
comment sessions at the meeting, you must indicate this at the time of
registration. FDA has included general topics for comment in this
document. You should also indicate which topic you wish to address in
your presentation. In order to keep each open session focused on the
topic at hand, each oral presentation should address only one topic.
FDA will do its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is to
begin.
Registration is free and will be on a first-come-first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration the day of the public meeting
will be provided on a space-available basis beginning at 7:30 a.m. Non-
U.S. citizens are subject to additional security screening, and they
should register as soon as possible.
Requests to make oral presentations, as well as presentation
materials, must be sent to the contact person by March 21, 2011. If you
need special accommodations due to a disability, please contact Susan
Monahan, 301-796-5661 or Susan.Monahan@fda.hhs.gov, no later than March
31, 2011.
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Devices and Radiological Health (CDRH) is exploring
the development of a searchable medical device labeling repository that
would be accessible by the public and provide useful product
information to patients and health care practitioners. This might be
similar to the labeling repository specific to drugs that is already
available through DailyMed on the National Library of Medicine's Web
site (http://www.dailymed.nlm.nih.gov/dailymed/about.cfm). The
repository could eventually cover all classes of devices and could
facilitate patient access to information on what types of devices are
available for their medical condition and how the devices could be
used. It could also assist health care professionals to access labeling
that may not always accompany a medical device.
FDA anticipates benefits for device manufacturers, including
improved information about potential predicate devices. The labeling
available in the repository might cover specific highlighted areas,
such as indications for use, operational instructions, warning and
precautions, and basic maintenance and cleaning. There might also be a
photo of the device and any acceptable accessories. We anticipate that
the repository would not include service and technical manuals or
supply any proprietary information.
CDRH is holding a public meeting to discuss any comments, concerns,
or questions the public may have about putting all device labeling onto
one Web site and to solicit input from the public on what they would
want and need in labeling and how they would want to access it. CDRH is
also interested in learning more about how patients, consumers, and
caregivers acquire and use medical device labeling and is seeking input
about the circumstances under which patients, consumers, and caregivers
receive or should receive risk-benefit information and instructions for
use for prescription and over-the-counter devices. In addition, CDRH
seeks input on which types of medical devices need patient labeling and
what elements that labeling should include. CDRH is also interested in
learning what resources, such as guidance or training, the public would
like it to provide in order to improve the quality of professional and
patient labeling.
The second topic to be discussed during this meeting is that of
public access to photographs of cleared medical devices. The CDRH
Preliminary Internal Evaluations 510(k) Working Group Report of August
2010 recommended that nonproprietary photos be made available in a
public database. In considering how to address this recommendation,
CDRH recognizes the sensitivity and potential confidentiality issues
with photos that would be made publicly available. Accordingly, CDRH is
interested in seeking feedback regarding the implementation of this
recommendation, including what guidance is needed to better ensure that
this recommendation may be implemented consistently and in a manner
that is useful to the public without adverse impact on industry.
II. Comments
FDA is holding this public meeting to obtain information on a
number of issues regarding FDA's plans to establish an online public
repository of medical device labeling and strategies for displaying
device photographs available in a public database without disclosing
proprietary information. FDA believes development of a searchable
online labeling repository holds many potential benefits for industry,
consumers, and health care providers. However, FDA is aware of the
concerns some members of industry have expressed about the costs of
submitting labeling to FDA. FDA is particularly interested in comments
on the costs and benefits of establishing an online labeling repository
and is soliciting comments on the following issues:
1. FDA has statutory authority to require the annual submission of
updated device labeling as part of the annual registration and listing
process under section 510(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(j)). FDA could rely on this authority to develop a
device labeling repository. An alternative approach would be to link to
labeling contained on manufacturers' Web sites; however, information
about devices no longer being marketed may not be maintained on those
sites. What are the advantages and disadvantages of these alternative
approaches? Do other alternatives exist to developing a searchable
online device labeling repository?
2. ``Labeling'' is a broad term that can cover practitioner
labeling, patient labeling, instructional manuals, and other materials.
What types of labeling should be included in an online repository?
3. There is currently no regulation mandating the content and
format of labeling for most devices. How can FDA define the type of
labeling that must be included in the repository to ensure consistency
across products and to ensure the most important information is
included in the repository?
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments up to 4 weeks before
and after the public workshop (March 10, 2011, through May 10, 2011)
regarding
[[Page 14030]]
this document. Submit electronic comments to http://www.regulations.gov. Submit 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. It is no longer necessary to send two copies of mailed
comments. Comments are to be identified with the docket number found in
brackets in the heading of this document. In addition, when responding
to specific discussion topics as outlined in this document, 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.
III. 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 (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5950 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P