[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