Document ID: FDA-2010-N-0291-0001
Agency: fda
Document Type: Notice
Title: Converged Communications and Health Care Devices Impact on Regulation; Public Meeting; Request for Comments
Posted Date: 2010-06-17T04:00Z

[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]               
[Page 34459-34461]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn10-81]                         

-----------------------------------------------------------------------

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 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

[[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 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