[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Proposed Rules]
[Pages 56702-56704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19580]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. 2007N-0308]


Medical Devices; Cardiovascular Devices; Electrocardiograph 
Electrode; Designation of Special Controls

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the classification regulation for the electrocardiograph electrode 
device to establish special controls and to exempt the device from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act (the act). The agency is taking this action on its own 
initiative. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a draft guidance document that would 
serve as the special control for the device if the rule is finalized. 
The agency believes that special controls, when followed and combined 
with the general controls, will provide reasonable assurance of the 
safety and effectiveness of these devices, if this proposal becomes 
final.

DATES: Submit written or electronic comments by January 2, 2008. See 
section VI of this document for the proposed effective date of a final 
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0308, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously in 
the ADDRESSES portion of this paragraph under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The act (21 U.S.C. 301 et seq.), as amended by the Medical Device 
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe 
Medical Devices Act (SMDA) (Public Law 101-629), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the act (21 U.S.C. 360c) 
established three categories (classes) of devices, depending on the 
regulatory controls needed to provide reasonable assurance of their 
safety and effectiveness. The three categories of devices are class I 
(general controls), class II (special controls), and class III 
(premarket approval).
    Under section 513 of the act, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments), as preamendments devices. Under the 1976 
amendments, class II devices are identified as those devices in which 
general controls by themselves are insufficient to provide reasonable 
assurance of safety and effectiveness of the device, but for which 
there is sufficient information to establish a performance standard to 
provide such assurance.
    SMDA broadened the definition of class II devices to include those 
devices for which general controls would not provide reasonable 
assurance of safety and effectiveness, but for which there is 
sufficient information to establish special controls to provide such 
assurance. The special controls include performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and any other appropriate 
actions the agency deems necessary to provide such assurance. (See 
section 513(a)(1)(B) of the act.)
    FDAMA added, among other sections, section 510(m) to the act (21 
U.S.C. 360(m)). Under section 510(m) of the act, FDA may exempt a class 
II device from premarket notification requirements (510(k)), if the 
agency determines that premarket notification is not necessary to 
assure the safety and effectiveness of the device. This section 
requires FDA to publish in the Federal Register a notice of intent to 
exempt a device and provide a comment period.

II. Regulatory History of the Device

    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 1976 amendments. 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.

III. Proposed Rule

    FDA is proposing to amend the classification regulation of the 
electrocardiograph electrode device in order to designate a special 
control for the device. The device was classified before the provisions 
of SMDA broadened the definition of class II devices to establish 
special controls beyond performance standards. Therefore, designating a 
special controls guidance document as a means to provide reasonable 
assurance of the safety and effectiveness of the device was not a 
regulatory option at the time of the original classification.
    Under the authority provided by SMDA, FDA is now able to propose 
the designation of a draft guidance

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document as a special control the agency believes will, together with 
the general controls, reasonably assure the safety and effectiveness of 
the device. FDA is identifying the draft guidance document entitled 
``Class II Special Controls Guidance Document: Electrocardiograph 
Electrodes'' as the proposed special control for the electrocardiograph 
electrode device. This draft guidance document describes means by which 
the device may comply with the requirement of special controls for 
class II devices. The draft guidance document identifies the issues 
associated with the device and recommends measures to address the 
issues.
    Under section 510(m)(2) of the act, FDA is proposing to exempt the 
device from premarket notification, subject to the limitations of Sec.  
870.9 (21 CFR 870.9), if the device addresses the issues identified in 
the special controls guidance by following the specific measures 
recommended in the special controls guidance.

IV. Risks to Health

    FDA has identified the following risks to health associated with 
these devices: Adverse tissue reaction to the skin-contacting electrode 
materials and misdiagnosis.

A. Adverse Tissue Reaction to the Skin-Contacting Electrode Materials

    Some of the skin contacting materials of the electrode may not be 
biocompatible. Inadequate biocompatibility may result in adverse tissue 
reactions such as redness, burning sensation, and rash.

B. Misdiagnosis

    Inadequate electrical performance may result in poor signal 
measurement. Inadequate labeling regarding proper electrical 
performance may result in improper use and cause poor signal 
measurement. Poor signal measurement may result in misdiagnosis of 
cardiac conditions.

V. Special Controls

    FDA believes that, in addition to general controls, the class II 
special controls draft guidance document entitled ``Class II Special 
Controls Guidance: Electrocardiograph Electrodes'' is an adequate 
special control to help address the risks to health described in 
section IV of this document. The class II special controls draft 
guidance document provides information on how to mitigate the risks to 
health of adverse tissue reaction to skin contacting electrode 
materials and misdiagnosis, by recommending testing and labeling.
    Several consensus standards describe electrical performance testing 
and properties to address the risk of misdiagnosis. Another consensus 
standard recommends biocompatibility testing, which can address the 
risk of adverse tissue reaction by ensuring that the device materials 
are sufficiently biocompatible for use on the skin.
    The labeling recommendations in the draft guidance document address 
the risk of improper use by recommending that manufacturers, consistent 
with the general labeling provisions of 21 CFR part 801, include the 
duration of application to the skin, instructions for skin preparation, 
and instructions for electrode preparation, cleaning, and maintenance 
in their labeling.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability of the draft guidance document that would 
serve as the special control for these devices.

VI. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register. If finalized, following the effective date of a final 
rule, any firm intending to market the device will need to address the 
issues covered in the special controls guidance. The firm must show in 
its 510(k) that its device meets the requirements of 21 CFR 807.87 and 
complies with the special controls, either by following the 
recommendations of the special controls guidance or, in some other way, 
providing equivalent assurances of safety and effectiveness. 
Manufacturers who follow the specific measures recommended to address 
the issues identified in the special controls guidance will be able to 
market their devices without being subject to the premarket 
notification requirements of section 510(k) of the act, subject to the 
limitations of Sec.  870.9. Manufacturers who choose alternative means 
to address one or more of the issues identified in the special controls 
guidance will remain subject to the premarket notification requirements 
of section 510(k) and must obtain marketing clearance for their device.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is not a significant regulatory action as defined by 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA believes that manufacturers are already 
substantially in compliance with the recommendations in the draft 
guidance document and exemption from the premarket notification 
requirements for devices following the specific measures recommended in 
the special control will simplify the entry to market for other 
manufacturers, including small manufacturers, the agency certifies that 
the proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $122 million, using the most current (2005) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IX. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and

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the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, the agency has 
tentatively concluded that the proposed rule does not contain policies 
that have federalism implications as defined in the Executive order 
and, consequently, a federalism summary impact statement has not been 
prepared.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520) is not required.
    FDA also tentatively concludes that the draft special control 
guidance document does not contain new information collection 
provisions that are subject to review and clearance by OMB under the 
PRA. Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice announcing the availability of the draft guidance document 
entitled ``Class II Special Controls Guidance Document: 
Electrocardiograph Electrodes;'' the notice contains an analysis of the 
paperwork burden for the draft guidance.

XI. 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.

List of Subjects in 21 CFR Part 870

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

    1. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. In Sec.  870.2360, paragraph (b) is revised to read as follows:


Sec.  870.2360   Electrocardiograph electrode.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for the device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Electrocardiograph Electrodes.'' 
See Sec.  870.1(e) for the availability of this guidance document. The 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec.  
870.9, if it addresses the issues identified in the special controls 
guidance by following the specific measures recommended in the special 
controls guidance.

    Dated: September 26, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-19580 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S