[Federal Register Volume 69, Number 184 (Thursday, September 23, 2004)]
[Rules and Regulations]
[Pages 56934-56936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2004N-0370]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the Beta-Glucan Serological Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
beta-glucan serological reagent device 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: Serological Assays for the Detection of Beta-Glucan.'' 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 1976 amendments), the Safe 
Medical Devices Act of 1990, the Food and Drug Administration 
Modernization Act of 1997, and the Medical Device User Fee and 
Modernization Act of 2002. 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 publishing a notice of availability of a 
guidance document that is the special control for this device.

DATES: This rule becomes effective October 25, 2004. The classification 
was effective May 21, 2004.

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, 301-594-2096, ext. 111.

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 (the 1976 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

[[Page 56935]]

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 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 (21 U.S.C. 360c(a) 
(1)). 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 (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued a 
notice on March 18, 2004, classifying the beta-glucan serological assay 
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, 2004, Associates of Cape Cod submitted a petition requesting 
classification of the beta-glucan serological assay 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 beta-
glucan serological assay 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 ``Beta-glucan serological 
assays'' and it is identified as a device that consists of antigens or 
proteases used in serological tests. It is intended for use in the 
presumptive diagnosis of fungal infection. The assay is indicated for 
use in patients with symptoms of, or medical conditions predisposing 
the patient to, invasive fungal infection. The device can be used as an 
aid in the diagnosis of deep-seated mycoses and fungemias. The assay 
should be used in conjunction with other diagnostic procedures, such as 
microbiological culture, histological examination of biopsy samples and 
radiological examination.
    FDA has not identified any direct risks to health when tests are 
used as an aid to detecting invasive fungal infection. However, failure 
of the test to perform as indicated, or an error in interpretation of 
results, could lead to misdiagnosis, improper treatment and improper 
patient management. Therefore, in addition to the general controls of 
the act, the device is subject to special controls, identified as the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Serological Assays for the Detection of Beta-Glucan.''
    The class II special controls guidance document provides 
information on how to meet premarket (510(k)) submission requirements 
for the device including recommendations on validation of performance 
characteristics. FDA believes that following the class II special 
controls guidance document addresses the risks to health identified in 
the previous paragraph. Therefore, on May 21, 2004, FDA issued an order 
to the petitioner classifying the device into class II. FDA is 
codifying this classification by adding 21 CFR 866.3050.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for beta-glucan 
serological assays 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, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness; therefore, the device 
is not exempt from premarket notification requirements. The device is 
used as an adjunct in detecting invasive fungal infection. FDA's review 
of the test's sensitivity, specificity, and reproducibility with regard 
to key performance characteristics, test methodology and other relevant 
performance data, 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 
beta-glucan serological assay they intend to market.

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 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 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. 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

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potential competitors to enter the marketplace by lowering their costs. 
The agency, therefore, certifies that the final rule will not have a 
significant impact on a substantial number of small entities. In 
addition, this final rule will not impose costs of $100 million or more 
on either the private sector or State, local, and tribal governments in 
the aggregate and, therefore, a summary statement of analysis under 
section 202(a) of the Unfunded Mandates Reform Act is not 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 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 under the Paperwork 
Reduction Act of 1995 is not required.

VI. Reference

    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 Associates of Cape Cod dated March 22, 2004.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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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.

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2. Section 866.3050 is added to subpart D to read as follows:


Sec. 866.3050  Beta-glucan serological assays.

    (a) Identification. Beta-glucan serological assays are devices that 
consist of antigens or proteases used in serological assays. The device 
is intended for use for the presumptive diagnosis of fungal infection. 
The assay is indicated for use in patients with symptoms of, or medical 
conditions predisposing the patient to invasive fungal infection. The 
device can be used as an aid in the diagnosis of deep seated mycoses 
and fungemias.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Serological Assays for the Detection of Beta-
Glucan.'' See Sec. 866.1(e) for the availability of this guidance 
document.

    Dated: September 10, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-21316 Filed 9-22-04; 8:45 am]
BILLING CODE 4160-01-S