[Federal Register: May 11, 2004 (Volume 69, Number 91)]
[Rules and Regulations]
[Page 26036-26038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my04-26]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2004P-0126]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Immunomagnetic Circulating Cancer Cell Selection
and Enumeration System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
Immunomagnetic Circulating Cancer Cell Selection and Enumeration 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: Immunomagnetic Circulating Cancer
Cell Selection and Enumeration System.'' 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 (the 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 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
[[Page 26037]]
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 June 10, 2004. The classification was
effective January 21, 2004.
FOR FURTHER INFORMATION CONTACT: Nina Chace, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1293, ext. 138.
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 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 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 notice in the Federal Register announcing
such classification (513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued a
notice on December 24, 2003, classifying the CellSearch Epithelial Cell
Kit/Cell Spotter Analyzer 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 December 24, 2003, Veridex, LLC, submitted
a petition requesting classification of the CellSearch Epithelial Cell
Kit/Cell Spotter Analyzer under section 513(f)(2) of the act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
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 CellSearch Epithelial Cell Kit/Cell
Spotter Analyzer 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 immunomagnetic circulating
cancer cell selection and enumeration system and is identified as a
device consisting of biological probes, fluorochromes, and other
reagents; preservation and preparation devices; and a semiautomated
analytical instrument to select and count circulating cancer cells in a
prepared sample of whole blood. This device is intended for adjunctive
use in monitoring or predicting cancer disease progression, response to
therapy, and for the detection of recurrent disease.
FDA has identified no direct risks to health when tests are used as
an aid to monitoring and predicting cancer disease progression and
response to therapy. However, failure of the test to perform as
indicated, or an error in interpretation of results, could lead to
misdiagnosis and improper treatment, improper patient management,
improper treatment selection and dosing, and failure to identify
circulating cancer cells. Consequently, FDA has identified the
following risks to health associated with this type of device: (1)
False negative, false low cancer cell count; and (2) false positive,
false high cancer cell count. 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: Immunomagnetic Circulating Cancer Cell
Selection and Enumeration System.''
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, including software validation; control methods;
reproducibility; and clinical studies. FDA believes that following the
class II special controls guidance document addresses the risks to
health identified in the previous paragraph. Therefore, on January 21,
2004, FDA issued an order to the petitioner classifying the device into
class II. FDA is codifying this classification by adding 21 CFR
866.6020.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for an immunomagnetic
circulating cancer cell selection and enumeration 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; therefore, the device
is not exempt from premarket notification requirements. The device is
used as an adjunct in monitoring or predicting cancer disease
progression and response to therapy and for detection of recurrent
disease. 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 ensure 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
immunomagnetic circulating cancer cell selection and enumeration system
they intend to market.
[[Page 26038]]
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 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 Veridex, LLC, dated December 24, 2003.
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 866.6020 is added to subpart G to read as follows:
Sec. 866.6020 Immunomagnetic circulating cancer cell selection and
enumeration system.
(a) Identification. An immunomagnetic circulating cancer cell
selection and enumeration system is a device that consists of
biological probes, fluorochromes, and other reagents; preservation and
preparation devices; and a semiautomated analytical instrument to
select and count circulating cancer cells in a prepared sample of whole
blood. This device is intended for adjunctive use in monitoring or
predicting cancer disease progression, response to therapy, and for the
detection of recurrent disease.
(b) Classification. Class II (special controls). The special
control for this device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Immunomagnetic Circulating Cancer
Cell Selection and Enumeration System.'' See Sec. 866.1(e) for
availability of this guidance document.
Dated: April 26, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-10592 Filed 5-10-04; 8:45 am]
BILLING CODE 4160-01-S