[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]
[Page 56771-56772]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0309]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Electrocardiograph
Electrodes; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Electrocardiograph Electrodes.'' The draft guidance
describes a means by which the electrocardiograph electrode device may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
proposed rule that would designate this draft guidance as the special
control for this device and would exempt the device from premarket
notification requirements, subject to specific limitations, if the
device addresses the issues identified in the guidance by following its
recommendations. The draft guidance document is not final, nor is it
being implemented at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 2, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Electrocardiograph Electrodes'' 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. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
[[Page 56772]]
Submit electronic comments to eitherhttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments orhttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices
and Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4095, or by e-mail at
Sharon.Lappalainen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 5, 1980 (45 FR 7926), FDA
issued a final rule classifying the electrocardiograph electrode into
class II, under the Federal Food, Drug, and Cosmetic Act (the act). An
electrocardiograph electrode is the electrical conductor which is
applied to the surface of the body to transmit the electrical signal at
the body surface to a processor that produces an electrocardiogram or
vectorcardiogram. FDA has now developed a draft guidance document for
the device and, under the act's provisions, is proposing to designate
the draft guidance as the special control that, when combined with the
general controls, the agency believes will provide a reasonable
assurance of the safety and effectiveness of this device type.
Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule that would designate this draft guidance document as
the special control for this device and would exempt the device from
premarket notification requirements, subject to limitations in 21 CFR
870.9, if the device addresses the issues identified in the special
controls guidance by following the draft guidance's recommendations.
The draft special controls guidance document identifies the
classification, product code, and classification identification for the
electrocardiograph electrode device. In addition, the draft guidance
document identifies the risks to health and serves as a special control
that, when followed and combined with the general controls, will
generally address the risks associated with this generic device type
and permit introduction of the device to the market.
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 the device.
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, regulations, or both.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Class II Special Controls
Guidance Document: Electrocardiograph Electrodes'' 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 (1597) 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485.
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 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: September 26, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-19578 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S