[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Rules and Regulations]
[Page 26290-26291]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my07-6]
[[Page 26290]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2007N-0136]
Medical Devices; Immunology and Microbiology Devices;
Classification of Gene Expression Profiling Test System for Breast
Cancer Prognosis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying gene
expression profiling test systems for breast cancer prognosis 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: Gene Expression Profiling Test System for Breast
Cancer Prognosis.'' 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 announcing the availability of the guidance document
that will serve as the special control for this device.
DATES: This final rule is effective June 8, 2007. The classification
was effective February 6, 2007.
FOR FURTHER INFORMATION CONTACT: Reena Philip, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-1286.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of This Rulemaking?
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 predicate 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 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 an
order on January 19, 2007, classifying the Agendia BV, MAMMAPRINT as
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. Agendia BV
submitted a petition dated January 22, 2007, requesting classification
of the MAMMAPRINT under section 513(f)(2) of the act. FDA filed the
petition on January 30, 2007. 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 Agendia
BV, MAMMAPRINT 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 ``gene expression profiling
test system for breast cancer prognosis.'' It is identified as a device
that measures the ribonucleic acid (RNA) expression level of multiple
genes and combines this information to yield a signature (pattern or
classifier or index) to aid in prognosis of previously diagnosed breast
cancer.
A gene expression profiling test system for breast cancer prognosis
is intended to provide prognostic information to aid in clinical
evaluation of breast cancer patients. Failure of this device to perform
as indicated may lead to erroneous test results. False positive results
will misclassify the patient into a higher risk group and false
negative results will misclassify the patient into a lower risk group.
Misclassification of cancer recurrence risk may lead to incorrect
prognosis with attendant psychological distress, inaccurate counseling,
and suboptimal patient care.
FDA believes the class II special controls guidance document will
aid in mitigating potential risks by providing recommendations on
labeling and validation of performance characteristics. The guidance
document also provides information on how to meet premarket (510(k))
submission requirements for the device. FDA believes that following the
class II special controls guidance document generally addresses the
risks to health identified in the previous paragraph. Therefore, on
February 6, 2007, FDA issued an order to the petitioner classifying the
device into class II. FDA is codifying this classification by adding
Sec. 866.6040.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a gene expression
profiling test system for breast cancer prognosis 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 review of the system's key performance
characteristics, test methodology, labeling, and other requirements as
outlined in Sec. 807.87, will provide reasonable assurance that
acceptable levels of performance for both safety and effectiveness will
be addressed before marketing clearance. Thus,
[[Page 26291]]
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 gene expression profiling test system for breast
cancer prognosis they intend to market.
II. What Is the Environmental Impact of This Rule?
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. What Is the Economic Impact of This Rule?
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 $122 million, using the most current (2005) 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. Does This Final Rule Have Federalism Implications?
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. How Does This Rule Comply With the 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. What References Are on Display?
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 Agendia BV, dated January 22, 2007.
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 866.6040 is added to subpart G to read as follows:
Sec. 866.6040 Gene expression profiling test system for breast cancer
prognosis.
(a) Identification. A gene expression profiling test system for
breast cancer prognosis is a device that measures the ribonucleic acid
(RNA) expression level of multiple genes and combines this information
to yield a signature (pattern or classifier or index) to aid in
prognosis of previously diagnosed breast cancer.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Gene Expression Profiling Test System for Breast
Cancer Prognosis.'' See Sec. 866.1(e) for the availability of this
guidance document.
Dated: May 1, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-8871 Filed 5-8-07; 8:45 am]
BILLING CODE 4160-01-S