[Federal Register: May 20, 2008 (Volume 73, Number 98)]
[Rules and Regulations]
[Page 29052-29054]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my08-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2008-N-0231]
Medical Devices; Immunology and Microbiology Devices;
Classification of Plasmodium Species Antigen Detection Assays
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying
Plasmodium species antigen detection assays into class II (special
controls). The special control that will apply to the device is the
guidance document entitled ``Class II Special Controls Guidance
Document: Plasmodium Species Antigen Detection Assays.'' 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
announcing the availability of the guidance document that will serve as
the special control for this device.
DATES: This rule is effective June 19, 2008. The classification was
effective June 13, 2007.
FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0712.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of This Rulemaking?
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (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 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 predicate 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 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
this classification (section 513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued an
order on February 22, 2007, classifying the Binax NOW[supreg] Malaria
Test 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 which was subsequently reclassified into class I or class II.
On March 22, 2007, Binax, Inc., submitted a petition requesting
classification of the Binax NOW[supreg] Malaria Test under section
513(f)(2) of the act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
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 Binax
NOW[supreg] Malaria Test 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 ``Plasmodium species
antigen detection assays.'' It is identified as a device that employs
antibodies for the detection of specific malaria parasite antigens,
including histidine-rich protein-2 (HRP2) specific antigens, and pan
malarial antigens in human whole blood. These devices are used for
testing specimens from individuals who have signs and symptoms
consistent with malaria infection. The detection of these antigens aids
in the clinical laboratory diagnosis of malaria caused by the four
malaria species capable of infecting humans: Plasmodium falciparum,
Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae, and aids
in the differential diagnosis of P. falciparum infections from other
less virulent Plasmodium species. The device is intended for use in
conjunction with other clinical laboratory findings.
FDA has identified the following risks to health associated with
the device. Failure of the test to perform as indicated may lead to
improper patient management and/or inappropriate public health
responses. For example, false negative results may lead to delays in
providing, or even failure to provide, definitive diagnosis and
appropriate treatment. A false positive test result may subject
individuals to unnecessary and/or inappropriate treatment for malaria,
and failure to appropriately diagnose and treat the actual disease
condition. The unnecessary use of alternative drugs, such as quinine,
mefloquine and artemisinin, typically used in high resistance areas
outside the United States, is problematic because these drugs are less
safe than the first and second line treatments.
In addition, malaria is a significant public health issue and is a
reportable disease to the Centers for Disease Control and Prevention.
Local and state health departments are required to conduct case
investigations upon receiving a report of a malaria infection. A false
positive test result could place an undue burden on local and state
health department resources and could also lead to unnecessary public
health actions (e.g., unnecessary or inappropriate treatment and
management of others in the community). On the other hand, a false
negative result could lead to a delay in recognition of increased
transmission of the parasitic infection.
An error in interpretation of results could also pose a risk,
especially decisions about treatment without confirmation of negative
results by
[[Page 29053]]
microscopy, which is more sensitive than antigen detection assays for
detecting malaria parasites in blood.
Table 1.--Risks to Health and Mitigation Measures
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Identified Risks Mitigation Measures
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Failure of the assay to perform Section 6. of the guidance--
properly, i.e., false negative or Performance Characteristics
false positive results which can Section 7. of the guidance--
lead to improper patient Labeling
management and/or inappropriate
public health responses
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Failure to properly interpret test Section 6. of the guidance--
results Performance Characteristics
Section 7. of the guidance--
Labeling
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FDA believes the class II special controls guidance document
generally addresses the risks to health identified in the previous
paragraphs. FDA believes the class II special controls guidance
document will aid in mitigating potential risks by providing
recommendations on labeling and validation of performance
characteristics. The guidance document also provides information on how
to meet 510(k) premarket notification submission requirements for the
device. FDA believes that the special controls, in addition to general
controls, address the risks to health identified previously and provide
reasonable assurances of the safety and effectiveness of the device
type. Therefore, on June 13, 2007, FDA issued an order to the
petitioner classifying the device into class II (Ref. 2). FDA is
codifying this classification by adding 21 CFR 866.3402.
Following the effective date of this final classification rule, any
firm submitting a premarket notification submission for a Plasmodium
species antigen detection assay will need to address the issues covered
in the special controls guidance. However, 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 to provide a
reasonable assurance of the safety and effectiveness of the device and,
therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the Plasmodium species
antigen detection assays they intend to market.
II. What Is the Environmental Impact of This Rule?
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.
III. What Is the Economic Impact of This Rule?
FDA has examined the impacts of the final 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 final 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 classification of this device into class II
will relieve manufacturers 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 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 $127 million, using the most current (2006) 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. Does This Final Rule Have Federalism Implications?
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. How Does This Rule Comply With the Paperwork Reduction Act of 1995?
This final rule contains no new information collection provisions.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 is not required.
VI. What References Are on Display?
The following references have 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 Binax, Inc., dated March 22, 2007.
2. Order classifying Binax NOW[reg] Malaria Test, dated June 13,
2007.
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:
[[Page 29054]]
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 866.3402 is added to subpart D to read as follows:
Sec. 866.3402 Plasmodium species antigen detection assays.
(a) Identification. A Plasmodium species antigen detection assay is
a device that employs antibodies for the detection of specific malaria
parasite antigens, including histidine-rich protein-2 (HRP2) specific
antigens, and pan malarial antigens in human whole blood. These devices
are used for testing specimens from individuals who have signs and
symptoms consistent with malaria infection. The detection of these
antigens aids in the clinical laboratory diagnosis of malaria caused by
the four malaria species capable of infecting humans: Plasmodium
falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium
malariae, and aids in the differential diagnosis of Plasmodium
falciparum infections from other less virulent Plasmodium species. The
device is intended for use in conjunction with other clinical
laboratory findings.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Plasmodium species Antigen Detection Assays.'' See
Sec. 866.1(e) for the availability of this guidance document.
Dated: April 30, 3008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-11263 Filed 5-19-08; 8:45 am]
BILLING CODE 4160-01-S