[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Proposed Rules]
[Page 56702-56704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-15]
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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announcing the availability of a draft guidance document that would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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, Sharon.Lappalainen@fda.hhs.gov.
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