Document ID: FDA-2007-D-0149-0006
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Availability: Class II Special Controls Guidance Document:  Electrocardiograph Electrodes
Posted Date: 2011-07-21T04:00Z

[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43690-43691]
From the Federal Register Online via the Government Printing 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 dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-P