[Federal Register Volume 71, Number 144 (Thursday, July 27, 2006)]
[Rules and Regulations]
[Pages 42596-42598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11975]


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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