[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Rules and Regulations]
[Pages 43582-43585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308)


Cardiovascular Devices; Classification of Electrocardiograph 
Electrodes

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
electrocardiograph electrode, 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 (special 
controls). FDA is also exempting this device from the premarket 
notification requirement.

DATES: This rule is effective August 22, 2011.

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, 301-796-
6322.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 
(SMDA) (Pub. L. 101-629), the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), and the Medical 
Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-
250), established a comprehensive system for the regulation

[[Page 43583]]

of medical devices intended for human use. Section 513 of the FD&C Act 
(21 U.S.C. 360c) established three categories (classes) of devices, 
defined by 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 FD&C 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.'' FDA classifies 
these devices after it takes the following steps: (1) Receives a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes a 
final regulation classifying the device. FDA has classified most 
preamendments devices under these procedures.
    Devices that were not in commercial distribution before May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically under section 513(f) of the FD&C Act into class III 
without any FDA rulemaking process. Those devices remain in class III 
until FDA does the following: (1) Reclassifies the device into class I 
or II; (2) issues an order classifying the device into class I or II in 
accordance with section 513(f)(2) of the FD&C Act; or (3) issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i) of the FD&C Act, to a legally marketed device that 
has been classified into class I or class II.
    The Agency determines whether new devices are substantially 
equivalent to previously marketed devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and 21 CFR part 807 of the regulations. FDAMA added a new 
section 510(m) to the FD&C Act. New section 510(m) provides that a 
class II device may be exempted from the premarket notification 
requirements under section 510(k) of the FD&C Act, if the Agency 
determines that premarket notification is not necessary to assure the 
safety and effectiveness of the device. FDA has determined that 
premarket notification is not necessary to assure the safety and 
effectiveness of electrocardiograph electrodes.
    Under the 1976 amendments, class II devices were defined as devices 
for which there was insufficient information to show that general 
controls themselves would provide reasonable assurance of safety and 
effectiveness, but for which there was sufficient information to 
establish performance standards to provide such assurance. SMDA 
broadened the definition of class II devices to mean those devices for 
which the general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, but for which there 
is sufficient information to establish special controls to provide such 
assurance, including performance standards, postmarket surveillance, 
patient registries, development and dissemination of guidelines, 
recommendations, and any other appropriate actions FDA deems necessary 
(section 513(a)(1)(B) of the FD&C Act). Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of the guidance 
document that will serve as the special control for this device. This 
action is being taken under the FD&C Act, as amended by the 1976 
amendments, SMDA, FDAMA, and MDUFMA.

II. Regulatory History of the Device

    In the Federal Register of October 4, 2007 (72 FR 56702; Docket No. 
2007N-0308), 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. FDA invited interested 
persons to comment on the proposed regulation by January 2, 2008. FDA 
received seven comments on the proposed rule.

III. Summary of Final Rule

    FDA is amending the classification regulation for 
electrocardiograph electrodes into class II, by making this device 
exempt from 510(k) premarket notification requirements and subject to 
the new special controls described in the special controls guidance 
document entitled ``Guidance for Industry and Food and Drug 
Administration Staff: Class II Special Controls Guidance Document: 
Electrocardiograph Electrodes.''
    As described in that special controls guidance document, the 
special controls include the following:
     Documentation of device description, which includes 
compliance with 21 CFR 820.181(a) to maintain a device master record;
     Documentation of performance characteristics, which 
includes documentation on biocompatibility, electrical performance, 
adhesive performance, shelf life, reuse, electrodes intended for use in 
specified procedures, sterility, and, with respect to electrode lead 
wires and patient cables, compliance with 21 CFR part 898; and
     Specific labeling, including indications for use, 
cautions, precautions, and adverse reactions.

Manufacturers must comply with the special controls as identified in 
that special controls guidance document, either by meeting the 
recommendations in the guidance document or by some other means that 
provides equivalent assurance of safety and effectiveness.

IV. Discussion of Comments

    The public comments received in response to the proposed rule 
addressed issues pertaining to labeling, the scope of the devices 
subject to the classification rule, and testing as follows:
    Regarding labeling, the comments requested the mandatory product 
labeling of all adhesive coated disposable electrocardiograph 
electrodes and the establishment of template labeling with which 
electrocardiograph electrodes should comply. In response, FDA has 
revised the labeling section of the special controls guidance document; 
however, FDA has not established template labeling.
    Regarding the scope of the devices subject to the notice, the 
comments requested a products-based definition or listing of examples 
to flesh out the ``type'' of devices that are consistent with Agency 
intent, requested a clarification of the type of sensor that is 
included in the scope of the classification, and requested a 
clarification if the list of environmental conditions is intended to be 
an exclusive list. In response, FDA has revised the special controls 
guidance document to clarify what the scope of this classification rule 
includes and excludes and to clarify what labeling should be reported 
regarding conditions of use.
    Regarding testing, the comments requested clarification of the 
shelf life, storage condition testing, and human clinical testing 
required to establish sensitivity and irritation for all adhesives. In 
response, FDA has revised the special controls guidance document to 
clarify testing for shelf life and has clarified the testing for 
biocompatibility.
    FDA is adopting in final form the assessment of the risks to public 
health stated in the proposed rule published on October 4, 2007, and 
agrees that the risk of electrical shock should also be taken

[[Page 43584]]

into account for purposes of this assessment. The guidance document has 
been revised accordingly. FDA is issuing this final rule which 
classifies the generic type of device, electrocardiograph electrode, 
into class II subject to special controls.

V. 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.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 final rule is not a significant 
regulatory action under the Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because manufacturers are already substantially in 
compliance with the recommendations in the guidance document and 
exemption from the premarket notification requirements for the devices 
following the specific measures recommended in the special control will 
simplify the entry to market for other manufacturers, the Agency 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities. In addition, this 
final rule will not impose costs of $100 million or more on either the 
private sector or state, local, and tribal governments in the 
aggregate, and therefore a written statement under section 202(a) of 
the Unfunded Mandates Reform Act of 1995 is not required.
    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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The specific measures recommended largely reflect current 
practices. With most manufacturers complying with most of the 
recommendations in the guidance document, any additional burden brought 
about by the final rule and guidance will likely be small.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe* * * a Federal statute to preempt State 
law only where the statute contains an express preemption provision or 
there is some other clear evidence that the Congress intended 
preemption of State law, or where the exercise of State authority 
conflicts with the exercise of Federal authority under the Federal 
statute.'' Federal law includes an express preemption provision that 
preempts certain state requirements ``different from or in addition 
to'' certain Federal requirements applicable to devices. 21 U.S.C. 
360k. See Medtronic v. Lohr, 518 U.S. 470 (1996); and Riegel v. 
Medtronic, 552 U.S. 312 (2008). The special controls established by 
this final rule create ``requirements'' to address each identified risk 
to health presented by these specific medical devices under 21 U.S.C. 
360k, even though product sponsors may have flexibility in how they 
meet those requirements Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 
740-42 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new 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.
    This final rule designates a guidance document as a special 
control. FDA also concludes that the special control guidance document 
does not contain new information collection provisions that are subject 
to review and clearance by OMB under the PRA.

IX. Electronic Access

    For access to the docket to read references or the public comments 
received, go to http://www.regulations.gov or go to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. A hard copy of any 
document can be obtained by submitting a Freedom of Information Act 
request to the Division of Freedom of Information (ELEM-1029), Food and 
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 
20857.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see section IX of this document) and 
may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday, or can be obtained in hardcopy by submitting a Freedom 
of Information Act request to the Division of Freedom of Information 
(see section IX of this document). (FDA has verified the Web site 
address, but we are not responsible for any subsequent changes to the 
Web site after this document publishes in the Federal Register.)

1. ``Class II Special Controls Guidance Document: Electrocardiograph 
Electrodes.''
2. ANSI/AAMI/ISO 10993-1, ``Biological Evaluation of Medical 
Devices--Part 1: Evaluation and Testing.''
3. ISO 10993-5, ``Biological Evaluation of Medical Devices--Part 5: 
Tests for In Vitro Cytotoxicity.''
4. ISO 10993-10, ``Biological Evaluation of Medical Devices--Part 
10: Tests for Irritation and Delayed Type Hypersensitivity.''
5. ANSI/AAMI EC12, ``Disposable ECG Electrodes.''
6. AAMI/ANSI/ISO ST79, ``Comprehensive Guide to Steam Sterilization 
and Sterility Assurance in Health Care Facilities.''
7. ``Updated 520(k) Sterility Review Guidance K90-1.''
8. IEC 601-1.56.3(c), ``Medical Electrical Equipment--Part 1, 
General Requirements for Safety.''
9. ANSI/AAMI EC53, ``ECG Cables and Leadwires.''
10. FDA Guidance 89-4203, ``Labeling--Regulatory Requirements for 
Medical Devices,'' available at http://www.fda.gov/cdrh/dsma/470.pdf.

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, 21 CFR part 
870 is amended as follows:

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PART 870--CARDIOVASCULAR DEVICES

0
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.


0
2. Revise paragraph (b) in Sec.  870.2360 to read as follows:


Sec.  870.2360  Electrocardiograph electrode.

* * * * *
    (b) Classification. Class II (special controls). 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. The 
special control for this device is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: Electrocardiograph 
Electrodes.'' See Sec.  870.1(e) for availability information of 
guidance documents.

    Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18391 Filed 7-20-11; 8:45 am]
BILLING CODE 4160-01-P