[Federal Register Volume 65, Number 226 (Wednesday, November 22, 2000)]
[Rules and Regulations]
[Pages 70305-70307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 00N-1565]


Immunology and Microbiology Devices; Classification of Anti-
Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test 
system into class II (special controls). The special control that will 
apply to this device is a guidance document entitled ``Guidance for 
Industry and FDA Reviewers: Class II Special Control Guidance Document 
for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) 
Premarket Notifications.'' Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of this guidance document. 
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, and the Food and Drug Administration Modernization Act of 1997. 
The agency is classifying these devices into class II (special 
controls) in order to provide a reasonable assurance of the safety and 
effectiveness of the devices.

DATES: This rule is effective December 22, 2000.

FOR FURTHER INFORMATION CONTACT: Deborah M. Moore, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

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, 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 
previously marketed 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 the FDA 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.

[[Page 70306]]

    In accordance with section 513(f)(1) of the act, FDA issued an 
order on July 11, 2000, classifying the QUANTA Lite<SUP>TM</SUP> ASCA 
(S. cerevisiae) IgG ELISA 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 July 18, 2000, FDA filed a petition 
submitted by INOVA Diagnostics, Inc., requesting classification of the 
QUANTA Lite<SUP>TM</SUP> ASCA (S. cerevisiae) IgG ELISA into class II 
under section 513(f)(2) of the act.
    After review of the information submitted in the petition, FDA 
determined that the INOVA Diagnostics QUANTA Lite<SUP>TM</SUP> ASCA (S. 
cerevisiae) IgG ELISA can be classified in class II with the 
establishment of special controls. This device is intended for use in 
the semi-quantitative in vitro determination of anti-Saccharomyces 
cerevisiae (S. cerevisiae) antibodies (ASCA) in human serum as an aid 
in the diagnosis of Crohn's disease. FDA believes that class II special 
controls, in addition to the general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    In addition to the general controls of the act, the INOVA 
Diagnostics QUANTA Lite<SUP>TM</SUP> ASCA (S. cerevisiae) IgG ELISA is 
subject to a special control guidance document entitled ``Guidance for 
Industry and FDA Reviewers: Class II Special Control Guidance for Anti-
Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket 
Notifications.''
    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, the device is 
not exempt from the premarket notification requirements. The test is 
used in the diagnosis of Crohn's disease and FDA review of data sets 
and labeling ensure that minimum levels of performance are obtained 
before marketing and are subject to impartial external quality control 
before labeling is put into place. Thus, persons who intend to market 
this device must submit to FDA a premarket notification submission 
containing information on the anti-Saccharomyces cerevisiae (S. 
cerevisiae) antibody (ASCA) test system before marketing the device.
    On August 16, 2000, FDA issued an order to the petitioner 
classifying the INOVA Diagnostics QUANTA Lite<SUP>TM</SUP> ASCA (S. 
cerevisiae) IgG ELISA, and substantially equivalent devices of this 
generic type, into class II under the generic name, anti-Saccharomyces 
cerevisiae (S. cerevisiae) antibody (ASCA) test system. FDA identifies 
this generic type of device as an anti-Saccharomyces cerevisiae (S. 
cerevisiae) antibody (ASCA) test system, which is intended to measure 
Saccharomyces cerevisiae (S. cerevisiae) antibodies (ASCA) in human 
serum or plasma as an aid in the diagnosis of Crohn's disease. FDA is 
codifying this device by adding Sec. 866.5785. This order also 
identified a special control applicable to this device entitled 
``Guidance for Industry and FDA Reviewers: Class II Special Control 
Guidance for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody 
(ASCA) Premarket Notifications.''

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.

III. Analysis 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) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), 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 consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive Order and so it is not 
subject to review 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices in class II will relieve this 
manufacturer 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 market place by 
lowering their costs. The agency, therefore, certifies that this 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 of anticipated costs and 
benefits before proposing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any one year (adjusted annually for 
inflation). The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for the final rule, because 
the final rule is not expected to result in any 1-year expenditure that 
would exceed $100 million.

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, or 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 order and, consequently, a federalism 
summary impact statement is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.
    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

    1. The authority citation for 21 CFR part 866 continues to read as 
follows:


[[Page 70307]]


    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 866.5785 is added to subpart F to read as follows:


Sec. 866.5785  Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody 
(ASCA) test systems.

    (a) Identification. The Anti-Saccharomyces cerevisiae (S. 
cerevisiae) antibody (ASCA) test system is an in vitro diagnostic 
device that consists of the reagents used to measure, by immunochemical 
techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in 
human serum or plasma. Detection of S. cerevisiae antibodies may aid in 
the diagnosis of Crohn's disease.
    (b) Classification. Class II (special controls). The special 
control is FDA's ``Guidance for Industry and FDA Reviewers: Class II 
Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. 
cerevisiae) Antibody (ASCA) Premarket Notifications.''

    Dated: November 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29841 Filed 11-21-00; 8:45 am]
BILLING CODE 4160-01-F