[Federal Register: July 27, 2006 (Volume 71, Number 144)]
[Rules and Regulations]
[Page 42596-42598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy06-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2006N-0276]
Medical Devices; Immunology and Microbiology Devices;
Classification of Fecal Calprotectin 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 fecal
calprotectin immunological test systems into class II (special
controls). The special control that will apply to these devices is the
guidance document entitled, ``Class II Special Controls Guidance
Document: Fecal Calprotectin Immunological Test Systems.'' The agency
is classifying these devices into class II (special controls) in order
to provide a reasonable assurance of safety and effectiveness of these
devices. 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 these devices.
DATES: This rule is effective August 28, 2006. The classification was
effective April 26, 2006.
FOR FURTHER INFORMATION CONTACT: Deborah Moore, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither
[[Page 42597]]
Rd., Rockville, MD 20850, 240-276-0493.
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 the
device is classified or reclassified into class I or class 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 March 21, 2006, classifying the Genova Diagnostics, Inc.
PhiCal\TM\ Fecal Calprotectin Immunoassay 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 March 23, 2006, Genova
Diagnostics, Inc. submitted a petition requesting classification of the
PhiCal\TM\ Fecal Calprotectin Immunoassay under section 513(f)(2) of
the act. The manufacturer recommended that the device be classified
into class II (Ref. 1).
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 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 Genova
Diagnostics, Inc. PhiCal\TM\ Fecal Calprotectin Immunoassay can be
classified into class II with the establishment of special controls.
FDA believes that special controls, in addition to general controls,
are adequate to provide reasonable assurance of the safety and
effectiveness of the device and that there is sufficient information to
establish special controls to provide such assurance.
The device is assigned the generic name ``fecal calprotectin
immunological test system,'' and it is identified as an in vitro
diagnostic device that consists of reagents used to quantitatively
measure, by immunochemical techniques, fecal calprotectin in human
stool specimens. The device is intended for in vitro diagnostic use as
an aid in the diagnosis of inflammatory bowel diseases (IBD),
specifically Crohn's disease and ulcerative colitis, and as an aid in
differentiation of IBD from irritable bowel syndrome.
FDA has identified the risks to health associated with this type of
device as inaccurate risk assessment and improper patient management.
Failure of the system to perform as indicated, or error in
interpretation of results, could lead to inaccurate risk assessment and
improper management of patients with IBD. Specifically, a falsely low
fecal calprotectin reading could result in a determination that the
patient does not have IBD, which could delay appropriate treatment. A
falsely high fecal calprotectin reading could result in a determination
that the patient has IBD, which could lead to unnecessary evaluation
and testing, or inappropriate treatment decisions. The use of assay
results without consideration of other diagnostic testing and the total
clinical picture could also pose a risk.
FDA believes that the class II special controls guidance document
will aid in mitigating the potential risks to health by providing
recommendations for the 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 the special controls guidance document, in addition
to general controls, addresses the risks to health identified in the
previous paragraph and provides reasonable assurances of the safety and
effectiveness of the device. Thus, on April, 26, 2006, FDA issued an
order to the petitioner classifying the device into class II. FDA is
codifying this classification at 21 CFR 866.5180.
Following the effective date of the final classification rule,
manufacturers will need to address the issues covered in this special
controls guidance. However, the manufacturer 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. FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Thus, this 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,
before marketing the device, which contains information about the fecal
calprotectin 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 a type that does not individually or cumulatively have a significant
effect on the human environment. Thus, 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
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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 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. 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. Thus,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) is not required. FDA concludes
that the special controls guidance document 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 guidance
document entitled, ``Class II Special Controls Guidance Document: Fecal
Calprotectin Immunological Test Systems.'' The notice contains an
analysis of the paperwork burden for the guidance.
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 Genova Diagnostics, Inc., for reclassification
of the PhiCal\TM\ Fecal Calprotectin Immunoassay submitted March 22,
2006.
List of Subjects in 21 CFR Part 866
Medical devices.
0
Thus, 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 866.5180 is added to subpart F to read as follows:
Sec. 866.5180 Fecal calprotectin immunological test system.
(a) Identification. A fecal calprotectin immunological test system
is an in vitro diagnostic device that consists of reagents used to
quantitatively measure, by immunochemical techniques, fecal
calprotectin in human stool specimens. The device is intended forin
vitro diagnostic use as an aid in the diagnosis of inflammatory bowel
diseases (IBD), specifically Crohn's disease and ulcerative colitis,
and as an aid in differentiation of IBD from irritable bowel syndrome.
(b) Classification. Class II (special controls). The special
control for these devices is FDA's guidance document entitled ``Class
II Special Controls Guidance Document: Fecal Calprotectin Immunological
Test Systems.'' For the availability of this guidance document, see
Sec. 866.1(e).
Dated: July 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-11975 Filed 7-26-06; 8:45 am]
BILLING CODE 4160-01-S