[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Rules and Regulations]
[Page 62007-62008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2003D-0221]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Endotoxin Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
endotoxin assay into class II (special controls). 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 amendments), the Safe Medical Devices Act of
1990 (SMDA), the Food and Drug Administration Modernization Act of 1997
(FDAMA), and the Medical Device User Fee and Modernization Act of 2002
(MDUFMA). The agency is classifying this 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 a guidance document
that will serve as the special control for the device.
DATES: This rule is effective December 1, 2003.
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.
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 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 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) request FDA to classify the device under the criteria set
forth in section 513(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
issuing an order classifying the device, FDA will publish a notice in
the Federal Register announcing the classification.
On April 14, 2003, FDA received a petition submitted under section
513(f)(2) of the act by the Devices and Diagnostics Consulting Group,
Inc., seeking an evaluation of the automatic class III designation of
its ``endotoxin activity assay.'' In accordance with section 513(f)(1)
of the act, FDA issued an order classifying the device 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 that was
subsequently reclassified into class I or II. After reviewing
information submitted in the petition, FDA determined that the
endotoxin activity assay could be classified in class II under the
generic name, endotoxin assay, with the establishment of special
controls. This device is intended to measure endotoxin activity as an
aid in the risk assessment on the first day of the patient's admission
to the intensive care unit (ICU). 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.
FDA has identified the risk to health associated specifically with
this type of device as improper patient management. Therefore, in
addition to the general controls of the act, the device is subject to a
special controls guidance document entitled ``Class II Special Controls
Guidance Document: Endotoxin Assay.'' FDA believes this special
controls guidance document will reasonably assure the safety and
effectiveness of this type of device.
The class II special controls guidance provides information on how
to meet
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premarket notification submission (510(k)) requirements for the device,
including recommendations for labeling and performance studies. FDA
believes manufacturers of the device that adhere to the class II
special controls guidance will address the potential risk to health
identified in the previous paragraph.
Following the effective date of this final classification rule, any
firm submitting a 510(k) for an endotoxin assay will need to address
the issues covered in the special controls guidance document. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirement 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 and, therefore, the
device is not exempt from the premarket notification requirements. The
endotoxin assay is a device that uses serological techniques in whole
blood. The device is intended for use in conjunction with other
laboratory findings and clinical assessment of the patient to aid in
the risk assessment of critically ill patients for progression to
severe sepsis. FDA review of performance characteristics and labeling
will ensure that acceptable levels of performance for both safety and
effectiveness are addressed before marketing clearance. Thus, persons
who intend to market this device must submit to FDA a 510(k) containing
information on the endotoxin assay before marketing the device.
On June 16, 2003, FDA issued an order classifying the endotoxin
activity assay and substantially equivalent devices of this generic
type into class II. FDA identifies this generic type of device as an
endotoxin assay, which is intended for the use of serological
techniques in whole blood. The device is intended for use in
conjunction with other laboratory findings and clinical assessment of
the patient to aid in the risk assessment of critically ill patients
for progression to severe sepsis. The order also stated the endotoxin
activity assay is intended for use only on the first day of admission
to the ICU.
FDA is codifying the classification of this device by adding 21 CFR
866.3610. The order also identifies a special control applicable to
this device, a guidance document entitled ``Class II Special Controls
Guidance Document: Endotoxin Assay.'' Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of a guidance
document that will serve as the special control for the device.
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, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). 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
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, 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.
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 866.3610 is added to subpart D to read as follows:
866.3610 Endotoxin assay.
(a) Identification. An endotoxin assay is a device that uses
serological techniques in whole blood. The device is intended for use
in conjunction with other laboratory findings and clinical assessment
of the patient to aid in the risk assessment of critically ill patients
for progression to severe sepsis.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance entitled ``Class II Special
Controls Guidance Document: Endotoxin Assay.'' See Sec. 866.1(e) for
the availability of this guidance document.
Dated: October 17, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27392 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S