[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Pages 34459-34461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14687]
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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.
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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:
[email protected]; or Bruce Romano, Federal Communications
Commission, 445 12th St. SW., rm. 7-C140, Washington, DC 20554, 202-
418-2470, email: [email protected].
Registration and Requests for Oral Presentations: Registration
requests must be received by 5 p.m. EDT on July
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19, 2010. Interested persons may register by emailing [email protected]. 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 [email protected] 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 http://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: http://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
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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 http://www.regulations.gov and in
the FDA and FCC public reference rooms listed previously. This
information will also be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list) and from http://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 http://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