[Federal Register Volume 72, Number 6 (Wednesday, January 10, 2007)]
[Rules and Regulations]
[Pages 1174-1176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-119]


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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