Draft Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices; Availability, 137-138 [E6-22449]
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Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
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Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–9927 Filed 12–28–06; 11:00 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0504]
Draft Guidance for Industry and Food
and Drug Administration Staff; RadioFrequency Wireless Technology in
Medical Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Draft Guidance for Industry
and FDA Staff; Radio-Frequency
Wireless Technology in Medical
Devices.’’ This draft guidance document
addresses issues relevant to the safe and
effective use of radio frequency (RF)
wireless technology in medical devices,
including wireless coexistence,
performance, data integrity, security,
and electromagnetic compatibility
(EMC). These issues involve all stages of
the product life cycle and should be
considered in preparing premarket
submissions; identifying, documenting,
and implementing product design
requirements, as well as design
verification and validation; and risk
management processes and procedures.
DATES: Submit written or electronic
comments on the draft guidance by
April 2, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance
VerDate Aug<31>2005
19:02 Dec 29, 2006
Jkt 211001
entitled ‘‘Draft Guidance for Industry
and FDA Staff: Radio-Frequency
Wireless Technology in Medical
Devices’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 240–276–
3151.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
FOR FURTHER INFORMATION CONTACT:
Donald Witters, Center for Devices and
Radiological Health (HFZ–130), Food
and Drug Administration, 12725
Twinbrook Pkwy., Rockville, MD 20852,
301–827–4955.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft
guidance document to assist industry,
systems and service providers,
consultants, FDA staff, and others in the
design, development, and evaluation of
RF wireless technology in medical
devices. The RF wireless emissions from
one product or device can affect the
function of another, the electromagnetic
environments where medical devices
are used may contain many sources of
RF energy, and the use of RF wireless
technology in and around medical
devices is increasing. As a result, the
draft guidance recommends that
manufacturers address concerns about
the potential effects of the use of RF
wireless technology in and around
medical devices on the ability of
medical devices to function properly
and the resultant safety of patients and
operators.
This draft guidance references
national and international standards
and discusses some of FDA’s regulatory
requirements, including premarket
requirements (21 CFR parts 807 and
814). The draft guidance document also
discusses quality system requirements
as they specifically apply to RF wireless
technology in medical devices,
including design and development
activities (21 CFR part 820).
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
137
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on RF wireless technology in and
around medical devices. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Draft Guidance
for Industry and FDA Staff; RadioFrequency Wireless Technology in
Medical Devices’’ you may either send
an e-mail request to dsmica@fda.hhs.gov
to receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number 1618 to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807 have
been approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231; and the collections
E:\FR\FM\03JAN1.SGM
03JAN1
138
Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or submit two paper copies of
any mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS.)
Dated: December 21, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–9952 Filed 12–29–06; 8:45 am]
of information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–22449 Filed 12–29–06; 8:45 am]
National Institutes of Health
BILLING CODE 4160–01–S
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Closed Meeting
rwilkins on PROD1PC63 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
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The meeting will be closed to the
public in accordance with the
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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 Cancer
Institute Initial Review Group, Subcommittee
J—Population and Patient-Oriented Training.
Date: February 19–20, 2007.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Arlington Gateway, 801
North Glebe Road, Arlington, VA 22203.
Contact Person: Ilda M McKenna, PhD,
Scientific Review Administrator, Research
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Boulevard Room
8111, Bethesda, MD 20892, 301–496–7481,
mckennai@mail.nih.gov.
VerDate Aug<31>2005
19:02 Dec 29, 2006
Jkt 211001
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Name of Committee: National Institute of
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Date: January 7–8, 2007.
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Place: Embassy Suites at the Chevy Chase
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Contact Person: Katherine Woodbury, PhD,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
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9529, (301) 496–5980, kw47o@nih.gov.
This notice is being published less than 15
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Name of Committee: National Institute of
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Date: January 9, 2007.
Time: 2 p.m. to 3:30 p.m.
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PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Raul A. Saavedra PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS, NSC; 6001
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Agenda: To review and evaluate grant
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Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: William C. Benzing, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
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Center, 6001 Executive Boulevard, Suite
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Conference Call).
Contact Person: Shantadurga Rajaram,
PHD, Scientific Review Administrator,
Scientific Review Branch, NIH/NINDS/
Neuroscience Center, 6001 Executive Blvd.,
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This notice is being published less than 15
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Name of Committee: National Institute of
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Date: January 12, 2007.
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Conference Call).
Contact Person: Joann McConnell, PhD,
Scientific Review Administrator, Scientific
Review Branch, NIH/NINDS/Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
Msc 9529, Bethesda, MD 20892–9529, (301)
496–5324, mcconnej@ninds.nih.gov.
E:\FR\FM\03JAN1.SGM
03JAN1
Agencies
[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Notices]
[Pages 137-138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22449]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0504]
Draft Guidance for Industry and Food and Drug Administration
Staff; Radio-Frequency Wireless Technology in Medical Devices;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical
Devices.'' This draft guidance document addresses issues relevant to
the safe and effective use of radio frequency (RF) wireless technology
in medical devices, including wireless coexistence, performance, data
integrity, security, and electromagnetic compatibility (EMC). These
issues involve all stages of the product life cycle and should be
considered in preparing premarket submissions; identifying,
documenting, and implementing product design requirements, as well as
design verification and validation; and risk management processes and
procedures.
DATES: Submit written or electronic comments on the draft guidance by
April 2, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Draft Guidance for Industry and FDA Staff: Radio-
Frequency Wireless Technology in Medical Devices'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 240-276-3151.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Donald Witters, Center for Devices and
Radiological Health (HFZ-130), Food and Drug Administration, 12725
Twinbrook Pkwy., Rockville, MD 20852, 301-827-4955.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft guidance document to assist industry,
systems and service providers, consultants, FDA staff, and others in
the design, development, and evaluation of RF wireless technology in
medical devices. The RF wireless emissions from one product or device
can affect the function of another, the electromagnetic environments
where medical devices are used may contain many sources of RF energy,
and the use of RF wireless technology in and around medical devices is
increasing. As a result, the draft guidance recommends that
manufacturers address concerns about the potential effects of the use
of RF wireless technology in and around medical devices on the ability
of medical devices to function properly and the resultant safety of
patients and operators.
This draft guidance references national and international standards
and discusses some of FDA's regulatory requirements, including
premarket requirements (21 CFR parts 807 and 814). The draft guidance
document also discusses quality system requirements as they
specifically apply to RF wireless technology in medical devices,
including design and development activities (21 CFR part 820).
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on RF wireless
technology in and around medical devices. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Draft Guidance for Industry and
FDA Staff; Radio-Frequency Wireless Technology in Medical Devices'' you
may either send an e-mail request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 240-276-3151
to receive a hard copy. Please use the document number 1618 to identify
the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 807 have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; and the collections
[[Page 138]]
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or submit two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: December 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-22449 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S