2011-18390. 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.

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 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 § 870.2360 (21 CFR 870.2360). In order to be classified as a class II device under § 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 [e-mail] 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.