Converged Communications and Health Care Devices Impact on Regulation; Public Meeting; Request for Comments, 34459-34461 [2010-14687]
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Dated: June 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–14623 Filed 6–16–10; 8:45 am]
[FR Doc. 2010–14624 Filed 6–16–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Center for Injury Prevention
and Control/Initial Review Group,
(NCIPC/IRG)
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control/Initial Review Group,
(NCIPC/IRG)
Correction: This notice was published
in the Federal Register on February 18,
2010, Volume 75, Number 32, page
7284. The notice should read as follows:
NCIPC/IRG Workgroup: Research
Grants for Preventing Violence and
Violence–Related Injury, Funding
Opportunity Announcement CE10–005.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned review group:
mstockstill on DSKH9S0YB1PROD with NOTICES
Times and Dates:
8 a.m.–5 p.m., March 11, 2010 (Closed)
8 a.m.–5 p.m., March 12, 2010 (Closed)
Place: JW Marriott Hotel Buckhead, 3300
Lenox Road, Atlanta, Georgia 30326,
Telephone (404) 262–3344.
Status: This meeting was closed to the
public in accordance with provisions set
forth in 41 CFR part 102 of the General
Services Administration Federal Advisory
Committee Management Final Rule.
Matters to be Discussed: The meeting
included the review, discussion, and
evaluation of applications intended to
expand and advance the understanding of
violence, its causes, and prevention
strategies. Requests for Applications are
related to the following individual research
announcement: CE10–005.
Agenda items are subject to change as
priorities dictate.
FOR FURTHER INFORMATION CONTACT: J.
Felix Rogers, PhD, M.P.H., NCIPC/
ERPO, CDC, 4770 Buford Highway, NE.,
M/S F63, Atlanta, Georgia 30341–3724,
Telephone (770) 488–4334.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
VerDate Mar<15>2010
16:13 Jun 16, 2010
Jkt 220001
Correction: This notice was published
in the Federal Register on February 1,
2010, Volume 75, Number 20, pages
5089–5090. The notice should read as
follows:
NCIPC/IRG Workgroup: Preventing
Unintentional Childhood Injuries (R21),
Funding Opportunity Announcement
CE10–001.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned review group:
Time and Date: 12:30 p.m.—4 p.m.,
February 16, 2010 (Closed).
Place: Teleconference.
Status: This meeting was closed to the
public in accordance with provisions set
forth in 41 CFR part 102 of the General
Services Administration Federal Advisory
Committee Management Final Rule.
Matters To Be Discussed: The meeting
included the review, discussion, and
evaluation of cooperative agreement
applications submitted in response to Fiscal
Year 2010 Requests for Applications related
to the following individual research
announcement: CE10–001.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact: J. Felix
Rogers, PhD, M.P.H., Telephone (770)488–
4334, NCIPC/ERPO, CDC, 4770 Buford
Highway, NE., M/S F63, Atlanta, Georgia
30341–3724.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–14622 Filed 6–16–10; 8:45 am]
BILLING CODE 4163–18–P
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34459
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0291]
Converged Communications and
Health Care Devices Impact on
Regulation; Public Meeting; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice of public meeting;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) and the Federal
Communications Commission (FCC) are
jointly sponsoring a public meeting
entitled ‘‘Enabling the Convergence of
Communications and Medical Systems:
Ways to Update Regulatory and
Information Processes.’’ The purpose of
this meeting is to identify the challenges
and risks posed by the proliferation of
new sophisticated medical implants and
other devices that utilize radio
communications to effectuate their
function, as well as challenges and risks
posed by the development and
integration of broadband
communications technology with
healthcare devices and applications.
While the general format for this
meeting is outlined in this document,
the details will be further informed by
the comments received, and a final
agenda will be published on the Internet
in the future.
Dates and Times: The public meeting
is scheduled for July 26 and 27, 2010,
from 8 a.m. to 5:30 p.m. Persons
interested in attending and/or
participating in the meeting must
register by 5 p.m. EDT on July 19, 2010.
Submit either electronic or written
comments related to the agenda, by 5
p.m. EDT on June 25, 2010. All other
comments must be submitted by August
16, 2010.
Location: The public meeting will be
held at the FCC Commission Meeting
Room, 445 12th St. SW., Washington,
DC 20554.
Contact Persons: Bakul Patel, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, rm.
3543, Silver Spring, MD 20993, 301–
796–5528, email:
bakul.patel@fda.hhs.gov; or Bruce
Romano, Federal Communications
Commission, 445 12th St. SW., rm. 7–
C140, Washington, DC 20554, 202–418–
2470, email: bruce.romano@fcc.gov.
Registration and Requests for Oral
Presentations: Registration requests
must be received by 5 p.m. EDT on July
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34460
Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
19, 2010. Interested persons may
register by emailing FCCFDAMeeting@fcc.gov. Registrants must
provide the following information: (1)
Name, (2) title, (3) company or
organization, (4) mailing address, (5)
telephone number, and (6) email
address. Registrants will receive
confirmation once they have been
accepted. Persons interested in
attending the meeting are encouraged to
register as registrants will have seating
priority in order of registration and can
be best assured of receiving information
by email regarding any changes that
may occur in meeting particulars. Also,
registration will be required for all
speakers. Overflow rooms with closed
circuit video monitors will be provided
as needed to accommodate the public.
FDA and FCC may limit the number of
registrants from each organization based
on space limitations.
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 and FCC have
included specific questions for
comment in section III of this document.
You should also identify which
discussion topic you wish to address in
your presentation. In order to keep each
open comment session focused on the
topic at hand, each oral presentation
should address only the topic specified
for that session. FDA and FCC will do
their 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 and FCC will
determine the amount of time allotted to
each presenter and the approximate
time that each oral presentation is
scheduled to begin.
If you need special accommodations
due to a disability, please send an email
to fcc504@fcc.gov or call the Consumer
and Governmental Affairs Bureau at
202–418–0530 (voice), 202–418–0432
(TTY) at least 7 days in advance of the
meeting.
Comments: FDA and FCC are holding
this public meeting to gather
information on a number of questions
regarding challenges and safety for
patients and other users of medical
devices that include radio elements and
of systems that can be tied into
broadband communication networks.
The deadline for submitting comments
related to the agenda is 5 p.m. EDT on
June 25, 2010. The comment period for
this public meeting closes on August 16,
2010.
Regardless of attendance at the public
meeting, interested persons may submit
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16:13 Jun 16, 2010
Jkt 220001
electronic comments to https://
www.regulations.gov, or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852 and to the
Federal Communications Commission,
Office of the Secretary, 445 12th St.
SW., rm. TW–A235, Washington, DC
20554. Send one paper copy of mailed
comments if you are submitting to FDA
and two paper copies of mailed
comments if you are submitting to FCC,
except that individuals may submit one
paper copy. Identify comments with the
docket number found in brackets in the
heading of this document (use docket
number ET 10–120 for written
submissions to FCC). In addition, when
responding to specific questions as
outlined in this document, please
identify the question you are
addressing. Received comments are
available at all times via the Federal
eRulemaking Portal: https://
www.regulations.gov. They may also be
seen in FDA’s Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday or at the
Federal Communications Commission,
Reference Information Center, 445 12th
St. SW., rm. CY–A257, Washington, DC
20554, Monday through Thursday
between 8 a.m. and 4:30 p.m. and on
Fridays between the hours of 8 a.m. and
12 noon.
SUPPLEMENTARY INFORMATION:
I. Background
There have been significant
developments in recent years in medical
and health care devices using radio
technology to monitor various body
functions and conditions, including
critical elements, and to deliver
treatment and therapy. There has also
been an increasing proliferation of
devices using established commercial
communications networks such as
Internet connectivity to communicate
with care providers. Mobile devices like
smartphones and personal digital
assistants (PDAs) are transforming the
transmission of information used by
physicians to help manage patient care,
including communication networks to
relay information for patient health
monitoring and decision support.
Examples of the latest implant or
body-worn monitoring, therapeutic, and
treatment technologies include blood
glucose monitors and automated insulin
pumps, heart monitors, pacemakers,
defibrillators, and neural pathway
replacements that stimulate muscle
movement.
Examples of devices and applications
that use commercial communications
networks and represent the convergence
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of communications and medicine
include a smartphone application that
displays real-time fetal heartbeat and
maternal contraction data allowing
obstetricians to track a mother’s labor
and wearable wireless patch-like
sensors that transmit health data over
commercial wireless networks to
practitioners, caregivers, and patients.
These and other products cover a
broad range of health care solutions. At
one end, general-purpose
communications devices such as
smartphones, wireless routers and
certain video-conferencing equipment
are regulated by FCC. At the other end,
medical devices that critically monitor
patient health or provide treatment or
therapy are regulated by FDA. Devices
that do provide critical care and also use
communications, such as life-critical
wireless devices like remotely
controlled drug-release mechanisms, are
regulated by both agencies. In addition,
device applications that would not be
governed by FCC but transmit over
wireless networks might warrant FDA
oversight, while FCC might have better
capability to assess the reliability of
their communications capability.
The objective of this meeting is to
gather information and to better
understand issues and perspectives
from various stakeholders so the
Agencies can identify potential areas
where each Agency’s jurisdiction can be
identified and clarified for affected
parties, collection and assessment of
each Agency’s respectively appropriate
information can be improved, expertise
can be shared, and regulatory approval
can be coordinated and simplified.
These concerns relate both to devices
operating on designated frequencies and
to convergent medical device and
information technology, as described
previously. This includes challenges
faced by manufacturers and innovators
in ensuring compliance with various
regulatory requirements and risks
associated with medical device systems
using spectrum shared by other medical
devices, using spectrum shared by other
types of devices and services, and using
broadband communication capabilities.
FDA and FCC recognize the need to
work with all stakeholders to identify
pathways and strive to improve
processes that will help continue to
spur innovation in these areas while
maintaining safety and effectiveness and
promoting public health.
II. Public Meeting
The information gathered during the
meeting will be used to enhance the
coordination between FDA and FCC for
such devices and applications, and
clarify and delineate the respective
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
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areas of expertise and jurisdiction
between the Agencies. This information
will simplify and expedite the
introduction of new and important
medical technologies and techniques
while maintaining safety and efficacy
levels appropriate to the various
technologies and devices.
During each session, members of the
public may present oral comments
related to the topic of that session.
Specific questions for comment are
listed in section III of this document.
Individuals who are interested in giving
an oral presentation during any of the
sessions must indicate this interest at
the time of registration and must also
identify the session(s) at which they
would like to present (see Registration
and Requests for Oral Presentation). In
order to keep each session focused on
the topic at hand, each oral presentation
should address only the topic specified
for that session. Persons who wish to
comment are free to submit written
comments on any topic(s) to the open
docket (see Comments). FDA and FCC
will schedule speakers for each session
as time permits.
In advance of the meeting, additional
information, including a meeting agenda
with a speakers’ schedule for each
session, will be made available on the
Internet. This information will be
placed on file in the public docket
(docket number found in brackets in the
heading of this document), which is
available at https://www.regulations.gov
and in the FDA and FCC public
reference rooms listed previously. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list) and from https://
www.fcc.gov/workshops.
III. Questions for Comment
FDA and FCC are planning to focus
the public meeting on the following
topics:
1. Data integrity and reliability issues
arising from the use of allocated
spectrum, the use of unlicensed devices,
and the use of commercial networks and
applications, and needs, uses, and risks
for ‘medical-grade’ wireless technology
and communications.
2. Medical device and system security
issues—inadvertent and intentional
intrusion—nonfunction and
malfunction.
3. Trends in medical devices using
allocated spectrum and using
unlicensed operation, and medical
devices and applications using
commercial networks. Consideration of
various wireless networking scenarios
and use cases.
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4. Risks Management:
• The need to define levels of
‘‘criticality’’ of device function that can
be used for determining reliability
requirements.
• Environmental factors and delivery
setting—hospitals, users, clinics, home,
travel, etc.
5. Views on current FDA and FCC
regulatory requirements:
• Relationship between FDA
approval/clearance and FCC
certification of applications, post market
and compliance requirements.
Each of the previous topics will cover:
1. Defining topics and scope;
2. Identifying the needs, goals, and
stakeholders; and
3. Recommendations.
FDA and FCC are seeking comments
on the topics and soliciting suggestions
on alternate or additional topics that
commenters deem closely related. All
comments and suggestions will be
considered with the constraint of
completing the workshop in no more
than 2 days. To be considered, topics
proposed must be relevant to the
objective and intent of the workshop.
IV. Transcripts
Transcripts of the public meeting may
be requested in writing from the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers Lane, rm. 6–30, Rockville, MD
20857 or at the Federal Communications
Commission, Reference Information
Center, 445 12th St. SW., rm. CY–A257,
Washington, DC 20554, Monday
through Thursday, between the hours of
8 a.m. and 4:30 p.m. and on Fridays
between 8 a.m. and 12 noon,
approximately 15 working days after the
public meeting at a cost of 10 cents per
page. A transcript of the public meeting
will be available on the Internet at
https://www.regulations.gov.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–14687 Filed 6–14–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
PO 00000
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34461
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Effectiveness Research on Smoking Cessation
in Hospitalized Patients.
Date: June 22–23, 2010.
Time: 6 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Shelley S. Sehnert, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7206,
Bethesda, MD 20892–7924. 301–435–
0303.ssehnert@nhlbi.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: June 11, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–14648 Filed 6–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Pages 34459-34461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14687]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0291]
Converged Communications and Health Care Devices Impact on
Regulation; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the Federal
Communications Commission (FCC) are jointly sponsoring a public meeting
entitled ``Enabling the Convergence of Communications and Medical
Systems: Ways to Update Regulatory and Information Processes.'' The
purpose of this meeting is to identify the challenges and risks posed
by the proliferation of new sophisticated medical implants and other
devices that utilize radio communications to effectuate their function,
as well as challenges and risks posed by the development and
integration of broadband communications technology with healthcare
devices and applications. While the general format for this meeting is
outlined in this document, the details will be further informed by the
comments received, and a final agenda will be published on the Internet
in the future.
Dates and Times: The public meeting is scheduled for July 26 and
27, 2010, from 8 a.m. to 5:30 p.m. Persons interested in attending and/
or participating in the meeting must register by 5 p.m. EDT on July 19,
2010. Submit either electronic or written comments related to the
agenda, by 5 p.m. EDT on June 25, 2010. All other comments must be
submitted by August 16, 2010.
Location: The public meeting will be held at the FCC Commission
Meeting Room, 445 12th St. SW., Washington, DC 20554.
Contact Persons: Bakul Patel, Food and Drug Administration, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, rm. 3543, Silver Spring, MD 20993, 301-796-5528, email:
bakul.patel@fda.hhs.gov; or Bruce Romano, Federal Communications
Commission, 445 12th St. SW., rm. 7-C140, Washington, DC 20554, 202-
418-2470, email: bruce.romano@fcc.gov.
Registration and Requests for Oral Presentations: Registration
requests must be received by 5 p.m. EDT on July
[[Page 34460]]
19, 2010. Interested persons may register by emailing FCC-FDAMeeting@fcc.gov. Registrants must provide the following information:
(1) Name, (2) title, (3) company or organization, (4) mailing address,
(5) telephone number, and (6) email address. Registrants will receive
confirmation once they have been accepted. Persons interested in
attending the meeting are encouraged to register as registrants will
have seating priority in order of registration and can be best assured
of receiving information by email regarding any changes that may occur
in meeting particulars. Also, registration will be required for all
speakers. Overflow rooms with closed circuit video monitors will be
provided as needed to accommodate the public. FDA and FCC may limit the
number of registrants from each organization based on space
limitations.
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 and FCC have included specific questions for comment
in section III of this document. You should also identify which
discussion topic you wish to address in your presentation. In order to
keep each open comment session focused on the topic at hand, each oral
presentation should address only the topic specified for that session.
FDA and FCC will do their 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 and FCC will determine the amount of time
allotted to each presenter and the approximate time that each oral
presentation is scheduled to begin.
If you need special accommodations due to a disability, please send
an email to fcc504@fcc.gov or call the Consumer and Governmental
Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY) at least 7
days in advance of the meeting.
Comments: FDA and FCC are holding this public meeting to gather
information on a number of questions regarding challenges and safety
for patients and other users of medical devices that include radio
elements and of systems that can be tied into broadband communication
networks. The deadline for submitting comments related to the agenda is
5 p.m. EDT on June 25, 2010. The comment period for this public meeting
closes on August 16, 2010.
Regardless of attendance at the public meeting, interested persons
may submit electronic comments to https://www.regulations.gov, or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852 and to the Federal Communications Commission, Office of the
Secretary, 445 12th St. SW., rm. TW-A235, Washington, DC 20554. Send
one paper copy of mailed comments if you are submitting to FDA and two
paper copies of mailed comments if you are submitting to FCC, except
that individuals may submit one paper copy. Identify comments with the
docket number found in brackets in the heading of this document (use
docket number ET 10-120 for written submissions to FCC). In addition,
when responding to specific questions as outlined in this document,
please identify the question you are addressing. Received comments are
available at all times via the Federal eRulemaking Portal: https://www.regulations.gov. They may also be seen in FDA's Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday or at the
Federal Communications Commission, Reference Information Center, 445
12th St. SW., rm. CY-A257, Washington, DC 20554, Monday through
Thursday between 8 a.m. and 4:30 p.m. and on Fridays between the hours
of 8 a.m. and 12 noon.
SUPPLEMENTARY INFORMATION:
I. Background
There have been significant developments in recent years in medical
and health care devices using radio technology to monitor various body
functions and conditions, including critical elements, and to deliver
treatment and therapy. There has also been an increasing proliferation
of devices using established commercial communications networks such as
Internet connectivity to communicate with care providers. Mobile
devices like smartphones and personal digital assistants (PDAs) are
transforming the transmission of information used by physicians to help
manage patient care, including communication networks to relay
information for patient health monitoring and decision support.
Examples of the latest implant or body-worn monitoring,
therapeutic, and treatment technologies include blood glucose monitors
and automated insulin pumps, heart monitors, pacemakers,
defibrillators, and neural pathway replacements that stimulate muscle
movement.
Examples of devices and applications that use commercial
communications networks and represent the convergence of communications
and medicine include a smartphone application that displays real-time
fetal heartbeat and maternal contraction data allowing obstetricians to
track a mother's labor and wearable wireless patch-like sensors that
transmit health data over commercial wireless networks to
practitioners, caregivers, and patients.
These and other products cover a broad range of health care
solutions. At one end, general-purpose communications devices such as
smartphones, wireless routers and certain video-conferencing equipment
are regulated by FCC. At the other end, medical devices that critically
monitor patient health or provide treatment or therapy are regulated by
FDA. Devices that do provide critical care and also use communications,
such as life-critical wireless devices like remotely controlled drug-
release mechanisms, are regulated by both agencies. In addition, device
applications that would not be governed by FCC but transmit over
wireless networks might warrant FDA oversight, while FCC might have
better capability to assess the reliability of their communications
capability.
The objective of this meeting is to gather information and to
better understand issues and perspectives from various stakeholders so
the Agencies can identify potential areas where each Agency's
jurisdiction can be identified and clarified for affected parties,
collection and assessment of each Agency's respectively appropriate
information can be improved, expertise can be shared, and regulatory
approval can be coordinated and simplified. These concerns relate both
to devices operating on designated frequencies and to convergent
medical device and information technology, as described previously.
This includes challenges faced by manufacturers and innovators in
ensuring compliance with various regulatory requirements and risks
associated with medical device systems using spectrum shared by other
medical devices, using spectrum shared by other types of devices and
services, and using broadband communication capabilities.
FDA and FCC recognize the need to work with all stakeholders to
identify pathways and strive to improve processes that will help
continue to spur innovation in these areas while maintaining safety and
effectiveness and promoting public health.
II. Public Meeting
The information gathered during the meeting will be used to enhance
the coordination between FDA and FCC for such devices and applications,
and clarify and delineate the respective
[[Page 34461]]
areas of expertise and jurisdiction between the Agencies. This
information will simplify and expedite the introduction of new and
important medical technologies and techniques while maintaining safety
and efficacy levels appropriate to the various technologies and
devices.
During each session, members of the public may present oral
comments related to the topic of that session. Specific questions for
comment are listed in section III of this document. Individuals who are
interested in giving an oral presentation during any of the sessions
must indicate this interest at the time of registration and must also
identify the session(s) at which they would like to present (see
Registration and Requests for Oral Presentation). In order to keep each
session focused on the topic at hand, each oral presentation should
address only the topic specified for that session. Persons who wish to
comment are free to submit written comments on any topic(s) to the open
docket (see Comments). FDA and FCC will schedule speakers for each
session as time permits.
In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule for each session, will be made
available on the Internet. This information will be placed on file in
the public docket (docket number found in brackets in the heading of
this document), which is available at https://www.regulations.gov and in
the FDA and FCC public reference rooms listed previously. This
information will also be available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list) and from https://www.fcc.gov/workshops.
III. Questions for Comment
FDA and FCC are planning to focus the public meeting on the
following topics:
1. Data integrity and reliability issues arising from the use of
allocated spectrum, the use of unlicensed devices, and the use of
commercial networks and applications, and needs, uses, and risks for
`medical-grade' wireless technology and communications.
2. Medical device and system security issues--inadvertent and
intentional intrusion--nonfunction and malfunction.
3. Trends in medical devices using allocated spectrum and using
unlicensed operation, and medical devices and applications using
commercial networks. Consideration of various wireless networking
scenarios and use cases.
4. Risks Management:
The need to define levels of ``criticality'' of device
function that can be used for determining reliability requirements.
Environmental factors and delivery setting--hospitals,
users, clinics, home, travel, etc.
5. Views on current FDA and FCC regulatory requirements:
Relationship between FDA approval/clearance and FCC
certification of applications, post market and compliance requirements.
Each of the previous topics will cover:
1. Defining topics and scope;
2. Identifying the needs, goals, and stakeholders; and
3. Recommendations.
FDA and FCC are seeking comments on the topics and soliciting
suggestions on alternate or additional topics that commenters deem
closely related. All comments and suggestions will be considered with
the constraint of completing the workshop in no more than 2 days. To be
considered, topics proposed must be relevant to the objective and
intent of the workshop.
IV. Transcripts
Transcripts of the public meeting may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857 or at
the Federal Communications Commission, Reference Information Center,
445 12th St. SW., rm. CY-A257, Washington, DC 20554, Monday through
Thursday, between the hours of 8 a.m. and 4:30 p.m. and on Fridays
between 8 a.m. and 12 noon, approximately 15 working days after the
public meeting at a cost of 10 cents per page. A transcript of the
public meeting will be available on the Internet at https://www.regulations.gov.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-14687 Filed 6-14-10; 4:15 pm]
BILLING CODE 4160-01-S
