[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Rules and Regulations]
[Pages 44380-44382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15475]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2007N-0294]
Medical Devices: Immunology and Microbiology Devices:
Classification of In Vitro Human Immunodeficiency Virus Drug Resistance
Genotype Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying an in
vitro human immunodeficiency virus (HIV) drug resistance genotype assay
into class II (special controls). The special control that will apply
to this device is the guidance document entitled ``Class II Special
Controls Guidance Document: In Vitro HIV Drug Resistance Genotype
Assay.'' FDA is classifying the device into class II (special controls)
in order to provide a reasonable assurance of safety and effectiveness
of this 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 becomes effective September 7, 2007. The
classification of this device into class II became effective on
September 26, 2001.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
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, 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. FDA 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 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.
In accordance with section 513(f)(1) of the act, FDA issued an
order on June 27, 2001, classifying into class III the
[[Page 44381]]
Visible Genetics, Inc., TRUEGENE HIV Genotyping Kit and OpenGene DNA
Sequencing System, because this device 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
to a device which was subsequently reclassified into class I or class
II. On July 11, 2001, Visible Genetics, Inc. submitted to FDA a
petition requesting classification of the TRUEGENE HIV Genotyping Kit
and OpenGene DNA Sequencing System 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 Visible
Genetics, Inc., TRUEGENE HIV Genotyping Kit and OpenGene DNA Sequencing
System can be classified in class II with the establishment of special
controls. FDA believes that special controls, in addition to general
controls, are adequate to provide reasonable assurance of the safety
and effectiveness of this device and that there is sufficient
information to establish special controls to provide such assurance.
This device is assigned the generic name, ``In vitro HIV drug
resistance genotype assay.'' It is identified as an in vitro diagnostic
device to be used to detect HIV genomic mutations that confer
resistance to specific types of antiretroviral drugs, as an aid in
monitoring and treating HIV infection.
FDA has identified the risks to health associated with the use of
the in vitro HIV drug resistance genotype assay. These risks include
inaccurate detection of resistance mutations present in a patient's
viral swarm that can result in continuance of therapies that are no
longer appropriate, or changes to new, inadequate therapies. In both
cases, the patient's viral load may increase, worsening the clinical
prognosis and accelerating the development of drug resistant viruses.
Patients may be needlessly subjected to serious, deleterious side
effects of inappropriate antiviral drugs. Furthermore, failure of the
assay to give any results at all (sequence failure) can deny or delay
beneficial, appropriate therapies, which may also result in high viral
loads and their attendant morbidity.
FDA believes that the class II special controls guidance document
will aid in mitigating the potential risks to health by providing
recommendations on performance characteristics; other considerations
such as design controls, statistical methods, and instruments and
software; product modification; and labeling. The guidance document
also provides recommendations for fulfilling the premarket (510(k))
submission requirements for this device. FDA believes that the class II
special controls guidance document, in addition to general controls,
addresses the risks to health identified in the previous paragraph and
provides reasonable assurance of the safety and effectiveness of the in
vitro HIV drug resistance assay. Therefore, on September 26, 2001, FDA
issued an order to the petitioner classifying the device into class II.
FDA is codifying this device classification at 21 CFR 866.3950.
Following the effective date of this final classification rule,
manufacturers submitting a 510(k) premarket notification for an in
vitro HIV drug resistance genotype assay will need to address the
issues covered in the special controls guidance. However, the
manufacturer 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. FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of this type of 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, before marketing the device, which contains information
about the in vitro HIV drug resistance genotype assay they intend to
market.
II. Analysis of Impacts
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 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 this device 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 $122 million, using the most current (2005) 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
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. 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
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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 (PRA) of 1995 is not required. 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: In Vitro HIV Drug Resistance
Genotype Assay.'' FDA concludes that the special controls guidance
document contains information collection provisions that are subject to
review by the OMB under the PRA and that have been approved by OMB in
accordance with the PRA under the regulations governing premarket
notification submissions (part 807, subpart E, OMB control number 0910-
0120).
VI. References
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 Visible Genetics, Inc., dated July 11, 2001.
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. Add Sec. 866.3950 to subpart D to read as follows:
Sec. 866.3950 In vitro human immunodeficiency virus (HIV) drug
resistance genotype assay.
(a) Identification. The in vitro HIV drug resistance genotype assay
is a device that consists of nucleic acid reagent primers and probes
together with software for predicting drug resistance/susceptibility
based on results obtained with these primers and probes. It is intended
for use in detecting HIV genomic mutations that confer resistance to
specific antiretroviral drugs, as an aid in monitoring and treating HIV
infection.
(b) Classification. Class II (special controls). The special
control for this device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: In Vitro HIV Drug Resistance
Genotype Assay.'' See Sec. 866.1(e) for the availability of this
guidance document.
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15475 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S