[Printable PDF]
[Federal Register: October 30, 2003 (Volume 68, Number 210)]
[Rules and Regulations]
[Page 61743-61745]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc03-9]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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