[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Rules and Regulations]
[Page 58258-58260]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. 2004P-0354]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of Sirolimus Test System Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
sirolimus test system 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: Sirolimus Test
Systems.'' The device is intended to measure sirolimus levels in whole
blood as an aid to managing therapy for transplant patients receiving
sirolimus, an immunosuppressive drug. 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 November 1, 2004. The classification
was effective July 28, 2004.
FOR FURTHER INFORMATION CONTACT: Avis Danishefsky, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 161.
SUPPLEMENTARY INFORMATION:
I. Background
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 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. 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 part 807 (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 order classifying the
device, FDA must publish a document 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
document on June 15, 2004, classifying the Microgenics CEDIA Sirolimus
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 June 16, 2004, Microgenics Corp. submitted a petition requesting
classification of the Microgenics CEDIA Sirolimus Assay under section
513(f)(2) of the act. The manufacturer recommended that the device be
classified into class II.
In accordance with 513(f)(2) of the act, FDA reviewed the petition
in order to classify the device under the criteria for classification
set forth in 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 Microgenics CEDIA Sirolimus 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 sirolimus test system and
is identified as a device intended to quantitatively determine
sirolimus concentrations in whole blood. Measurements are used as an
aid in management of transplant patients receiving therapy with
sirolimus.
FDA has identified no direct risks to health related to use of
sirolimus test systems. However, FDA has identified improper patient
management, which involves failure of the test to perform as indicated
or error in interpretation of results, as an indirect risk to health
related to use of this device. For example, a falsely low sirolimus
measurement could contribute to a decision to raise the sirolimus dose
above that which is necessary for therapeutic benefit. This could
result in increased risk in the form of thrombocytopenia, leukopenia,
anemia, or hyperlipidemia. A falsely high sirolimus measurement could
contribute to a decision to decrease the dose below
[[Page 58259]]
that which is necessary for immunosuppression. This could result in
increased risk of rejection of the transplanted organ. Since optimal
ranges for sirolimus may vary depending on the metabolite cross-
reactivity of the specific assay, as well as on clinical factors, use
of assay results to adjust a treatment regimen without consideration of
such factors could also lead to 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: Sirolimus Test
Systems.''
The class II special controls guidance document also provides
information on how to meet premarket (510(k)) submission requirements
for the device, including recommendations on validation of performance
characteristics and labeling. FDA believes that following the class II
special controls guidance document generally addresses the risks to
health identified in the previous paragraph. Therefore, on July 28,
2004, FDA issued an order to the petitioner classifying the device into
class II. FDA is codifying this classification by adding 21 CFR
862.3840.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a sirolimus test
system 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. FDA review of
performance characteristics, test methodology, and labeling to satisfy
requirements of Sec. 807.87(e), 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
containing information on the sirolimus test system they intend to
market, before marketing 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 (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 $110 million. FDA does not expect this final rule to
result in any 1-year expenditure that would meet or exceed this amount.
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 Microgenics Corp., dated June 16, 2004.
List of Subjects in 21 CFR Part 862
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
862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
0
1. The authority citation for 21 CFR part 862 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 862.3840 is added to subpart D to read as follows:
Sec. 862.3840 Sirolimus test system.
(a) Identification. A sirolimus test system is a device intended to
quantitatively determine sirolimus concentrations in whole blood.
Measurements are used as an aid in management of transplant patients
receiving therapy with sirolimus.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Sirolimus Test Systems.'' See Sec. 862.1(d) for the
availability of this guidance document.
[[Page 58260]]
Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22011 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S