[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43690-43691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18390]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0149] (Formerly 2007D-0309)
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 guidance entitled ``Class II Special Controls
Guidance Document: Electrocardiograph Electrodes.'' The special
controls identify the following risks to health associated with
electrocardiograph electrodes: Adverse tissue reaction to the skin-
contacting electrode materials and misdiagnosis. The guidance document
provides information on how to mitigate these risks and recommends
testing and labeling for these devices. This guidance document
describes a means by which electrocardiograph electrodes may comply
with the requirement of special controls for class II devices.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Electrocardiograph Electrodes'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the
[[Page 43691]]
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1238, Silver Spring, MD 20993-0002, 301-
796-6322.
SUPPLEMENTARY INFORMATION:
I. Background
The guidance describes a means by which electrocardiograph
electrodes may comply with the requirement of special controls for
class II devices. In the Federal Register of October 4, 2007 (72 FR
56771), and Docket No. FDA-2007D-0309, FDA proposed to classify
electrocardiograph electrodes, intended to acquire and transmit the
electrical signal at the body surface to a processor that produces an
electrocardiogram (ECG) or vectorcardiogram, into class II. FDA also
proposed to exempt this device from premarket notification requirements
and issued a draft guidance document to describe the special control
requirements. FDA invited interested persons to comment on the proposed
regulation and the draft guidance document by January 8, 2008. FDA
received seven comments on the proposed rule. These comments addressed
issues pertaining to labeling, the scope of the devices subject to the
classification rule, and testing. In response, FDA has revised the
labeling section of the guidance, has clarified the scope of the
guidance, and has clarified the information regarding testing for shelf
life. Elsewhere in this issue of the Federal Register, FDA is
publishing a final rule to classify electrocardiograph electrodes into
class II (special controls) and to exempt the device from 510(k)
premarket notification procedures.
II. Significance of Special Controls Guidance Document
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of
electrocardiograph electrodes classified under Sec. 870.2360 (21 CFR
870.2360). In order to be classified as a class II device under Sec.
870.2360, an electrocardiograph electrode must comply with the
requirements of special controls; manufacturers must address the issues
requiring special controls as identified in the guidance document,
either by following the recommendations in the guidance document or by
some other means that provides equivalent assurances of safety and
effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.
To receive ``Class II Special Controls Guidance Document:
Electrocardiograph Electrodes,'' you may either send an e-mail request
to [email protected] to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a paper copy. Please use
the document number (1597) to identify the guidance you are
requesting.
IV. Paperwork Reduction Act
This 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 parts 50 and 56 have been approved under OMB
control number 0910-0130; the collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; 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), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18390 Filed 7-20-11; 8:45 am]
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