[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Rules and Regulations]
[Page 57748-57750]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc05-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2005N-0341]
Medical Devices; Immunology and Microbiology Devices;
Classification of AFP-L3% Immunological Test Systems
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying AFP-L3%
(alpha-fetoprotein L3 subfraction) immunological 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: AFP-L3% Immunological 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
announcing the availability of a guidance document that will serve as
the special control for the device.
DATES: This rule is effective November 3, 2005. The classification was
effective May 19, 2005.
FOR FURTHER INFORMATION CONTACT: Maria Chan, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496.
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 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 April 1, 2005, classifying the Wako LBA (liquid-phase binding
assay) AFP-L3 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 that was subsequently reclassified into class I or class II.
On April 6, 2005, Wako Chemical USA, Inc., submitted a petition
requesting classification of the Wako AFP-L3 Test System 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 Wako LBA AFP-L3 Test System can be
classified into class II with the establishment of special controls.
FDA believes these special controls will provide reasonable assurance
of the safety and effectiveness of the device.
The device is assigned the generic name AFP-L3% immunological test
system and it is identified as an in vitro device that consists of
reagents and an automated instrument used to quantitatively measure, by
immunochemical techniques, AFP and AFP-L3 subfraction in human serum.
The device is intended for in vitro diagnostic use as an aid in the
risk assessment of patients with chronic liver disease for development
of hepatocellular carcinoma, in conjunction with other laboratory
findings, imaging studies, and clinical assessment.
FDA has identified the risks to health associated with this type of
device as inappropriate risk assessment and improper patient
management. Failure of the system to perform as indicated, or error in
interpretation of results, could lead to inappropriate risk assessment
and improper management of patients with chronic liver diseases.
Specifically, a falsely low AFP-L3% could result in a determination
that the patient is at a lower risk of developing hepatocellular
carcinoma, which could delay appropriate monitoring and treatment. A
falsely high AFP-L3% could result in a determination that the patient
is at a
[[Page 57749]]
higher risk for hepatocellular carcinoma, which could lead to
unnecessary evaluation and testing, or inappropriate treatment
decisions. Use of assay results without consideration of other
laboratory findings, imaging studies, and clinical assessment could
also pose a risk.
The class II special controls guidance document aids in mitigating
potential risks by providing recommendations on validation of
performance characteristics, including software validation, control
methods, reproducibility, and clinical studies. The guidance document
also provides information on how to meet premarket (510(k)) submission
requirements for the device. FDA believes that following the
recommendations in the class II special controls guidance document
generally addresses the risks to health identified in the previous
paragraph.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for an AFP-L3%
immunological 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 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 the safety
and effectiveness of the device and, therefore, the type of device is
not exempt from premarket notification requirements. 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 AFP-L3% immunological test system 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 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 as defined by
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 economic 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. How Does This Rule Comply with the Paperwork Reduction Act of 1995?
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3502) is not required.
FDA also tentatively concludes that the special controls guidance
document identified by this rule contains information collection
provisions that are subject to review and clearance by OMB under the
PRA. Elsewhere in this issue of the Federal Register, FDA is publishing
a notice announcing the availability of the draft guidance document
entitled ``Class II Special Controls Guidance Document: AFP-L3%
Immunological Test Systems.''
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 Wako Chemical USA, Inc., received April 7,
2005.
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 866.6030 is added to subpart G to read as follows:
Sec. 866.6030 AFP-L3% immunological test system.
(a) Identification. An AFP-L3% immunological test system is an in
vitro device that consists of reagents and an automated instrument used
to quantitatively measure, by immunochemical techniques, AFP and AFP-L3
subfraction in human serum. The device is intended for in vitro
[[Page 57750]]
diagnostic use as an aid in the risk assessment of patients with
chronic liver disease for development of hepatocellular carcinoma, in
conjunction with other laboratory findings, imaging studies, and
clinical assessment.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: AFP-L3% Immunological Test Systems.'' See Sec.
866.1(e) for the availability of this guidance document.
Dated: September 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-19863 Filed 10-3-05; 8:45 am]
BILLING CODE 4160-01-S