[Federal Register: January 10, 2007 (Volume 72, Number 6)]
[Rules and Regulations]
[Page 1174-1176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja07-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2006N-0517]
Medical Devices; Immunology and Microbiology Devices;
Classification of Quality Control Material for Cystic Fibrosis Nucleic
Acid Assays
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying quality
control material for cystic fibrosis nucleic acid 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: Quality Control Material for Cystic Fibrosis Nucleic Acid
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 final rule is effective February 9, 2007. The
classification was effective October 12, 2006.
FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 117.
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
[[Page 1175]]
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification (section 513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued an
order on August 7, 2006, classifying the Maine Molecular Quality
Controls, Inc., INTROL\TM\ CF Panel I Control as 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 August 10, 2006, Maine
Molecular Quality Controls, Inc., submitted a petition requesting
classification of the INTROL\TM\ CF Panel I Control 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 Maine
Molecular Quality Controls, Inc., INTROL\TM\ CF Panel I Control 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 ``quality control material
for cystic fibrosis nucleic acid assays.'' It is identified as a device
intended to help monitor reliability of a test system by detecting
analytical deviations such as those that may arise from reagent or
instrument variation in genetic testing. This type of device includes
recombinant, synthetic, and cell line based DNA controls.
Quality control (QC) material is intended to help monitor
reliability of a test system. Therefore, failure of the QC material for
cystic fibrosis nucleic acid assays to perform as indicated may lead to
error in assessment of test results, and reporting of inaccurate
results. This could potentially lead to patient mismanagement. For
example, if the controls fail even though the test system was accurate,
this may lead to unnecessary retesting, and delay in reporting results.
In cases of patient samples that are difficult to obtain, this may
cause additional risk to the patient. Conversely, if a QC material does
not accurately reflect when the test system has failed, this may lead
to false assurance of test operability, and reporting of inaccurate
patient results.
FDA believes the class II special controls guidance document will
aid in mitigating potential risks by providing recommendations on
validation of performance characteristics, and labeling specifications
appropriate for the use of controls in genetic in vitro diagnostic
assays. The guidance document also provides information on how to meet
premarket (510(k)) submission requirements for the device. FDA believes
that following the class II special controls guidance document
generally addresses the risks to health identified in the previous
paragraph. Therefore, on October 12, 2006, FDA issued an order to the
petitioner classifying the device into class II. FDA is codifying this
classification by adding Sec. 866.5910.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a quality control
material for genetic testing 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 review of the system's key performance
characteristics, test methodology, labeling, and other requirements as
outlined in 21 CFR 807.87, 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,
prior to marketing the device, which contains information about the
quality control material for cystic fibrosis nucleic acid 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, 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 $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.
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
[[Page 1176]]
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 collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 is not required.
The guidance for this final rule references previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E,
have been approved under OMB Control No. 0910-0120; the collections of
information in 21 CFR part 814 have been approved under OMB Control No
0910-0231; the collections of information in 21 CFR part 809 have been
approved under OMB Control No. 0910-0485.
VI. What References are on Display?
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 Maine Molecular Quality Controls, Inc., dated
August 10, 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 866.5910 is added to subpart F to read as follows:
Sec. 866.5910 Quality Control Material for Cystic Fibrosis Nucleic
Acid Assays.
(a) Identification. Quality control material for cystic fibrosis
nucleic acid assays. A quality control material for cystic fibrosis
nucleic acid assays is a device intended to help monitor reliability of
a test system by detecting analytical deviations such as those that may
arise from reagent or instrument variation in genetic testing. This
type of device includes recombinant, synthetic, and cell line-based DNA
controls.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic
Acid Assays.'' See Sec. 866.1(e) for the availability of this guidance
document.
Dated: December 21, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health
[FR Doc. E7-119 Filed 1-9-07; 8:45 am]
BILLING CODE 4160-01-S