[Federal Register: March 10, 2005 (Volume 70, Number 46)]
[Rules and Regulations]
[Page 11867-11869]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr05-18]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. 2005N-0071]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Instrumentation for Clinical Multiplex Test Systems
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying
instrumentation for clinical multiplex test systems 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: Instrumentation for Clinical Multiplex Test Systems.'' 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 is effective April 11, 2005. The classification was
effective December 23, 2004.
FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0443, ext. 159.
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 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 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 (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 October 29, 2004, classifying the Affymetrix GENECHIP
Microarray Instrumentation System 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 to a device that was subsequently reclassified
into class I or class II. On November 3, 2004, Affymetrix, Inc.,
submitted a petition requesting classification of the Affymetrix
GENECHIP Microarray Instrumentation System 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
Affymetrix GENECHIP Microarray Instrumentation System 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 ``instrumentation for
clinical multiplex test systems.'' It is identified as a device
intended to measure and sort multiple signals generated by an assay
from a clinical sample. This instrumentation is used with a specific
assay to measure multiple similar analytes that establish a single
indicator to aid in diagnosis. Such instrumentation may be compatible
with more than one specific assay. The device includes a signal reader
unit, and may also integrate reagent handling, hybridization, washing,
dedicated instrument control, and other hardware components, as well as
raw data storage mechanisms, data acquisition software, and software to
process detected signals.
FDA has identified the risks to health associated with this type of
device as potentially inaccurate results or inaccurate reports which
may lead to incorrect diagnoses or patient evaluation that could result
in inappropriate and possibly dangerous patient management.
Specifically,
[[Page 11868]]
failure of instrument components, including reagent introduction and
hybridization systems, signal detection mechanisms, instrument control
and data acquisition software, and raw data storage mechanisms could
lead to inaccurate results. Likewise, failure of data management and
database software could result in the compromise of patient
identification or mis-matched results. Furthermore, failure of the
instrumentation to generate any results at all can deny or delay
beneficial, appropriate therapies.
FDA believes that following the class II special controls guidance
document generally addresses the risks to health identified in the
previous paragraph. 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. Therefore, on December 23,
2004, FDA issued an order to the petitioner classifying the device into
class II. FDA is codifying this classification by adding 21 CFR
862.2570.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for instrumentation for
clinical multiplex test systems 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, however, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of safety and effectiveness. FDA's review of
performance characteristics, test methodology, and labeling to see that
it satisfies the 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
instrumentation for clinical multiplex test systems 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 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 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 this device 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 $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. 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 Affymetrix, Inc., dated November 3, 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 862.2570 is added to subpart C to read as follows:
Sec. 862.2570 Instrumentation for clinical multiplex test systems.
(a) Identification. Instrumentation for clinical multiplex test
systems is a device intended to measure and sort multiple signals
generated by an assay from a clinical sample. This instrumentation is
used with a specific assay to measure multiple similar analytes that
establish a single indicator to aid in diagnosis. Such instrumentation
may be compatible with more than one specific assay. The device
includes a signal reader unit, and may also integrate reagent handling,
hybridization, washing, dedicated
[[Page 11869]]
instrument control, and other hardware components, as well as raw data
storage mechanisms, data acquisition software, and software to process
detected signals.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Instrumentation for Clinical Multiplex Test
Systems.'' See Sec. 862.1(d) for the availability of this guidance
document.
Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4760 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S