[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33849-33851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13244]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0580]


Battery-Powered Medical Devices Workshop: Challenges and 
Opportunities; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Battery-Powered Medical Devices Workshop: 
Challenges and Opportunities''. The purpose of this workshop is to 
create awareness of the challenges related to battery-powered medical 
devices and collaboratively develop solutions and best practices to 
improve the performance and reliability of these devices.
    Date and Time: The public workshop will be held on July 30 and 31, 
2013, 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. All visiting public 
workshop participants (non-FDA employees) must enter through Building 1 
for routine security check procedures. For parking and security 
information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact: Iacovos Kyprianou, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 
66, Rm. 3609, Silver Spring, MD 20993-0002, 301-796-2601, email: 
iacovos.kyprianou@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 5 p.m., July 19, 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 workshop will be available beginning at 7 a.m.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://

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www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, and affiliation, address, email, and telephone 
number. Those without Internet access should contact Susan Monahan, 
susan.monahan@fda.hhs.gov or 301-796-5661, to register. Registrants 
will receive confirmation after they have been accepted. You will be 
notified if you are on a waiting list.
    If you need special accommodations due to a disability, please 
contact Susan Monahan (susan.monahan@fda.hhs.gov or 301-796-5661) no 
later than 5 p.m. on July 17, 2013.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 5 p.m., July 19, 2013. 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 July 24, 2013. If you have never attended an 
Adobe 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 
public comment and topic-focused sessions. If you wish to present, 
please so indicate at time of registration. Please indicate whether you 
wish to present during a public comment session, or participate in a 
specific session. Please submit the topic and a short abstract of your 
presentation. FDA will do its best to accommodate requests to make 
public comment and participate in specific sessions. 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 specific 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 July 22, 2013. All requests to make 
oral presentations must be received by the close of registration at 5 
p.m., July 19, 2013. If selected for presentation, any presentation 
materials must be emailed to Iacovos Kyprianou (see Contact) no later 
than July 24, 2013. No commercial 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 battery-powered medical devices. 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 and the issues discussed during the meeting is August 30, 
2013.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic or written comments. 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. Please identify comments with the docket 
number found in brackets in the heading of this document. In addition, 
when commenting on specific topics as outlined in section II of this 
document, please identify the topics 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).

SUPPLEMENTARY INFORMATION: 

I. Background

    Batteries play a significant role in the overall safety, 
performance, and reliability of many life-saving and life-sustaining 
medical devices. As more medical devices become computerized, compact, 
and mobile, the number of battery-powered medical devices will continue 
to increase. While many different components can potentially impact the 
safety and effectiveness of medical devices, the battery can be one of 
the most critical components. Unexpected depletion or failure of the 
battery can cause the device to stop functioning properly, preventing 
the device from delivering life-sustaining or life-saving therapy. The 
Association for the Advancement of Medical Instrumentation has 
identified battery management as one of the top 10 challenges for 
hospitals' biomedical departments. In addition, the way that the 
battery is integrated into the overall device plays a critical role in 
the performance of the device. In many cases, the cause of the problem 
is identified as ``battery failure'' even when the battery is not the 
root cause of the problem. Improper charging of rechargeable batteries 
and inconsistent maintenance of batteries in general can adversely 
impact the effectiveness of the device, causing unexpected failure of 
devices at critical times, such as emergency situations where 
electrical power is unavailable or intermittent. While FDA has 
confidence that medical devices currently being marketed will continue 
to function as intended, there are opportunities to further improve 
their overall performance and safety. Therefore, FDA is organizing a 
Battery-Powered Medical Devices Workshop on July 30 and 31, 2013, to 
create awareness of the challenges related to battery-powered medical 
devices and collaboratively develop solutions and best practices to 
improve the performance and reliability of these devices. The forum 
will be held at the FDA's White Oak campus in Silver Spring, MD from 8 
a.m. to 5 p.m. The participants would include a broad group of 
stakeholders that are responsible for the design, testing, 
manufacturing, integration, regulation, selection, purchase, storage, 
maintenance, and use of batteries throughout the total product life 
cycle of battery-powered medical devices.

II. Topics for Discussion

    At this meeting, participants will engage in open dialogue and 
discuss the following factors that contribute to battery-powered 
medical device performance and reliability:

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     Identification of challenges,
     Battery/device design and system integration,
     Battery/device manufacturing process,
     Battery/device maintenance,
     Human factors,
     Consistent labeling,
     User training,
     Special considerations under extreme conditions,
     Standardization,
     Emerging technology and innovation, and
     Mitigation of challenges.

Goals

    1. Create awareness of the challenges related to battery-powered 
medical devices and collaboratively develop solutions and best 
practices to improve the performance and reliability of these devices.
    2. Create a forum for open dialogue among stakeholders to share 
lessons learned and best practices for overcoming battery-powered 
medical device challenges.
    3. Promote better design, manufacturing, testing, system 
integration, maintenance and standardization of battery-powered medical 
devices.
    4. Understand the challenges of hospitals, health care providers, 
and patients in selection, purchase, use, and maintenance of battery-
powered medical devices.
    5. Promote innovation in technology and processes to improve device 
performance and reliability.
    6. Coordinate future collaboration in the development of 
educational materials, standards, and guidance.

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13244 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P