[Federal Register Volume 68, Number 210 (Thursday, October 30, 2003)]
[Rules and Regulations]
[Pages 61743-61745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2003P-0450]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the West Nile Virus IgM Capture Elisa Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the West 
Nile Virus IgM Capture Elisa assay into class II (special controls). 
The agency is taking this action in response to a petition submitted 
under the Federal Food, Drug, and Cosmetic Act (the act) as amended by 
the Medical Device Amendments of 1976 (the amendments), the Safe 
Medical Devices Act of 1990, and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). The agency is classifying this 
device into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a guidance document that will serve as the special 
control for the device.

DATES: This rule is effective December 1, 2003.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the amendments, generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. 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 
act (21 U.S.C. 360(k)) and 21 CFR part 807 of the FDA regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after issuing an order classifying the device, 
FDA must publish a notice in the Federal Register announcing the 
classification.
    On July 3, 2003, FDA received a petition submitted under section 
513(f)(2) of the act by PANBIO, Ltd. seeking an evaluation of the 
automatic class III designation of its West Nile Virus IgM Capture 
Elisa Assay. In accordance with section 513(f)(1) of the act, FDA 
issued an order automatically classifying the West Nile Virus IgM 
Capture Elisa Assay in class III because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device that was subsequently reclassified 
into class I or II. After reviewing information submitted in the 
petition, FDA determined that the West Nile Virus IgM Capture Elisa 
Assay can be classified in class II under the generic name, West Nile 
Virus, Serological Reagents, with the establishment of special 
controls. West Nile virus serological reagents are devices that consist 
of antigens and antisera for the detection of anti-West Nile virus IgM 
antibodies, in human serum, from individuals that have signs and 
symptoms consistent with viral meningitis/encephalitis. The detection 
aids in the clinical laboratory diagnosis

[[Page 61744]]

of viral meningitis/encephalitis caused by West Nile virus.
    FDA has identified the risk to health associated specifically with 
this type of device as improper patient management. Therefore, in 
addition to the general controls of the act, the device is subject to a 
special controls guidance document entitled ``Class II Special Controls 
Guidance Document: Serological Reagents for the Laboratory Diagnosis of 
West Nile Virus.''
    The class II special controls guidance provides information on how 
to meet premarket (510(k)) submission requirements for the device, 
including recommendations for labeling and performance studies. FDA 
believes that adherence to the class II special controls addresses the 
potential risk to health identified previously and provides a 
reasonable assurance of the safety and effectiveness of the device.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for West Nile virus 
serological reagents will need to address the issues covered in the 
special controls guidance document. However, the firm need only show 
that its device meets the recommendations of the guidance or in some 
other way provides equivalent assurances of safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness and, therefore, the 
device is not exempt from the premarket notification requirements. In 
general, West Nile virus serological reagents are devices that consist 
of antigens and antisera for the detection of anti-West Nile virus IgM 
antibodies, in human serum, from individuals that have signs and 
symptoms consistent with viral meningitis/encephalitis. The detection 
aids in the clinical laboratory diagnosis of viral meningitis/
encephalitis caused by West Nile virus.
    FDA review of performance characteristics and labeling will ensure 
that acceptable levels of performance for both safety and effectiveness 
are addressed before marketing clearance. Thus, persons who intend to 
market this device must submit to FDA a premarket notification 
submission containing information on West Nile virus serological 
reagents before marketing the device.
    On July 8, 2003, FDA issued an order classifying the West Nile 
Virus IgM Capture Elisa assay and substantially equivalent devices of 
this generic type into class II under the generic name, West Nile 
Virus, Serological Reagents. FDA identifies this generic type of device 
as West Nile virus serological reagents, which are devices that consist 
of antigens and antisera for the detection of anti-West Nile virus IgM 
antibodies, in human serum, from individuals that have signs and 
symptoms consistent with viral meningitis/encephalitis. The detection 
aids in the clinical laboratory diagnosis of viral meningitis/
encephalitis caused by West Nile virus.
    FDA is codifying this device by adding Sec.  866.3940. The order 
also identifies a special control applicable to this device, a guidance 
document entitled ``Class II Special Controls Guidance Document: West 
Nile Virus Serological Assay.''

II. Electronic Access

    In order to receive the guidance entitled ``Class II Special 
Controls Guidance Document: Serological Reagents for the Laboratory 
Diagnosis of West Nile Virus'' via your fax machine, call the CDRH 
Facts-on-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. At the first voice prompt press 1 to enter the system. 
At the second voice prompt press 1 to order a document. Enter the 
document number (1206) followed by the pound sign (). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Act of 1996 
(Public Law 104-121)), 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 final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive order and so it is not subject to 
review under 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices from class III to class II will 
relieve manufacturers of the device of the cost of complying with the 
premarket approval requirements of section 515 of the act (21 U.S.C. 
360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency, therefore, certifies 
that the final rule will not have a significant 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 
summary statement of analysis under section 202(a) of the Unfunded 
Mandates Reform Act is not required.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and

[[Page 61745]]

responsibilities among the various levels of government. Accordingly, 
the agency has concluded that the rule does not contain policies that 
have federalism implications as defined in the order and, consequently, 
a federalism summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 866.3940 is added to subpart D to read as follows:


Sec.  866.3940  West Nile virus serological reagents.

    (a) Identification. West Nile virus serological reagents are 
devices that consist of antigens and antisera for the detection of 
anti-West Nile virus IgM antibodies, in human serum, from individuals 
who have signs and symptoms consistent with viral meningitis/
encephalitis. The detection aids in the clinical laboratory diagnosis 
of viral meningitis/encephalitis caused by West Nile virus.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Serological Reagents for the Laboratory Diagnosis of West 
Nile Virus.'' See Sec.  866.1(e) for the availability of this guidance 
document.

    Dated: October 8, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27294 Filed 10-29-03; 8:45 am]
BILLING CODE 4160-01-S