[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Rules and Regulations]
[Page 14377-14379]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr06-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2006N-0100]
Medical Devices; Immunology and Microbiology Devices;
Classification of Reagents for Detection of Specific Novel Influenza A
Viruses
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying Reagents
for detection of specific novel influenza A viruses into class II
(special controls). Special controls that will apply to the device are
the guidance document entitled, ``Class II Special Controls Guidance
Document: Reagents for Detection of Specific Novel Influenza A
Viruses'' and limitations of distribution of these reagents. 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 Safe Medical Devices Act of
1990, the Food and Drug Administration Modernization Act of 1997, and
the Medical Device User Fee and Modernization Act of 2002. The agency
is classifying the 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
publishing a notice of availability of a guidance document that is a
special control for this device.
DATES: This rule becomes effective April 21, 2006. The classification
was effective February 3, 2006.
FOR FURTHER INFORMATION CONTACT: Claudia Gaffey, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496.
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 Medical Device Amendments of
1976 (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
[[Page 14378]]
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 part 807 (21 CFR part 807) of FDA's 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 the issuance of an order classifying the
device, FDA must publish a notice in the Federal Register announcing
such classification (513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued a
notice on January 26, 2006, classifying the Centers for Disease Control
and Prevention (CDC)'s Influenza A/H5 (Asian lineage) Virus Real-time
RT-PCR Primer and Probe Set in class III, because it was not
substantially equivalent to a class I or class II device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On January 26,
2006, CDC submitted a petition requesting classification of the
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe
Set under section 513(f)(2) of the act. The manufacturer recommended
that the device be classified into class II.
In accordance with section 513(f)(2) of the act, FDA reviewed the
petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the act. Devices are
to be classified into class II if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the CDC's
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe
Set can be classified in class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of safety and effectiveness
of the device. The device is assigned the generic name, ``Reagents for
detection of specific novel influenza A viruses.'' The Influenza A/H5
(Asian lineage) Virus Real-time RT-PCR Primer and Probe Set is intended
for the in vitro qualitative detection of Influenza A/H5 (Asian
lineage) virus RNA either directly in patient respiratory specimens or
in viral cultures for the presumptive laboratory identification of
Influenza A/H5 (Asian lineage) virus. Testing with the Influenza A/H5
(Asian lineage) Virus Real-time RT-PCR Primer and Probe Set should be
used in conjunction with other laboratory testing and clinical
observations for the following indications: (1) Providing
epidemiological information for the surveillance of human infection
with Influenza A/H5 (Asian lineage) virus; (2) identifying patients who
may be infected with Influenza A/H5 (Asian lineage) virus based on
clinical and epidemiological risk factors.
FDA has identified the risks to health associated with this type of
device as improper patient management and public health response,
laboratory-acquired infection, and potential influenza A virus
reassortment. Failure of testing with reagents for detection of
specific novel influenza A viruses to correctly identify a specific
novel influenza A virus, or failure to properly interpret test results
obtained with these reagents, could lead to incorrect patient
management decisions and inappropriate public health responses. Also,
the use of reagents for detection of specific novel influenza A viruses
without appropriate biosafety equipment and containment could result in
laboratory-acquired infection and viral reassortment.
The class II special controls guidance document provides
information on how to meet premarket (510(k)) submission requirements
for the device, including recommendations on validation of performance
characteristics and labeling. It also addresses postmarket measures to
assure the continued safety and effectiveness of the device by
identifying changes in performance that may result from mutation in the
virus that the device is intended to detect or changes in the
prevalence of human infection. FDA believes that following the class II
special controls guidance document and the additional special control
specified in the classification regulation generally addresses the
risks to health identified in the previous paragraph. Therefore, on
February 3, 2006, FDA issued an order to the petitioner classifying the
device into class II. FDA is codifying this classification by adding
Sec. 866.3332.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for reagents for
detection of specific novel influenza A viruses will need to address
the issues covered in the special controls guidance, which contains
recommendations for the contents of premarket notification submissions
including performance testing, labeling, and postmarket data collection
and analysis; and will have to limit distribution of these reagents to
laboratories with: (1) Experienced personnel who have training in
standardized molecular testing procedures and expertise in viral
diagnosis, and (2) appropriate biosafety equipment and containment.
However, regarding the issues covered in the special controls guidance,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurance of
safety and effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements 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, however, FDA has
determined that premarket notification is necessary because FDA review
of performance characteristics, test methodology, and labeling to
satisfy requirements of 21 CFR 807.87(e), will provide reasonable
assurance that acceptable levels of performance for both safety and
effectiveness will be addressed before marketing clearance. Thus,
persons who intend to market this type of device must submit to FDA a
premarket notification containing information on the reagents for
detection of specific novel influenza A viruses before marketing the
device.
II. 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.
[[Page 14379]]
III. 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), 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 not a significant regulatory action 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. Because classification of these devices into 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 certifies that the
final rule will not have a significant 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 $115 million, using the most current (2003) 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.
IV. 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 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 Executive Order and, consequently, a
federalism summary impact statement is not required.
V. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) is not required. FDA concludes
that the special controls guidance document contains 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 guidance
document entitled, ``Class II Special Controls Guidance Document:
Reagents for Detection of Specific Novel Influenza A Viruses''; the
notice contains an analysis of the paperwork burden for the guidance.
VI. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from CDC, dated January 26, 2006.
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, 371.
0
2. Section 866.3332 is added to subpart D to read as follows:
Sec. 866.3332 Reagents for detection of specific novel influenza A
viruses.
(a) Identification. Reagents for detection of specific novel
influenza A viruses are devices that are intended for use in a nucleic
acid amplification test to directly detect specific virus RNA in human
respiratory specimens or viral cultures. Detection of specific virus
RNA aids in the diagnosis of influenza caused by specific novel
influenza A viruses in patients with clinical risk of infection with
these viruses, and also aids in the presumptive laboratory
identification of specific novel influenza A viruses to provide
epidemiological information on influenza. These reagents include
primers, probes, and specific influenza A virus controls.
(b) Classification. Class II (special controls). The special
controls are:
(1) FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Reagents for Detection of Specific Novel Influenza A
Viruses.'' See Sec. 866.1(e) for information on obtaining this
document.
(2) The distribution of these devices is limited to laboratories
with experienced personnel who have training in standardized molecular
testing procedures and expertise in viral diagnosis, and appropriate
biosafety equipment and containment.
Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-2742 Filed 3-21-06; 8:45 am]
BILLING CODE 4160-01-S