[Federal Register: September 23, 2004 (Volume 69, Number 184)]
[Rules and Regulations]
[Page 56934-56936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se04-6]
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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
[[Page 56936]]
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.
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 866.3050 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