[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Pages 14028-14030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5950]



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.


    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 

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 
    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: [email protected].
    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 
    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 [email protected], no later than March 
31, 2011.


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) 

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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]