[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14272-14274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2012-N-0165]


Medical Devices; Immunology and Microbiology Devices; 
Classification of Norovirus Serological Reagents

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying 
norovirus serological reagents 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: 
Norovirus Serological Reagents.'' The Agency is classifying these 
devices into class II (special controls) because special controls, in 
addition to general controls, will provide a reasonable assurance of 
safety and effectiveness of these devices and there is sufficient 
information to establish special controls.

DATES: Effective Date: April 9, 2012. The classification was effective 
February 23, 2011.

FOR FURTHER INFORMATION CONTACT: Steven Gitterman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993-0002, 301-
796-6694.

SUPPLEMENTARY INFORMATION:

I. Legal Authority

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (FD&C 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 1976

[[Page 14273]]

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 FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to previous marketed devices by means of 
premarket notification procedures in section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C 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), request FDA to classify the device under the 
criteria set forth in section 513(a)(1). 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 FD&C Act).

II. Classification

    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on February 14, 2011, classifying the RIDASCREEN[supreg] 
Norovirus 3rd Generation EIA into 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 February 16, 2011, Lehnus and Associates 
Consulting, on behalf of R-Biopharm AG, submitted a petition requesting 
classification of the RIDASCREEN[supreg] Norovirus 3rd Generation EIA 
under section 513(f)(2) of the FD&C Act. The manufacturer recommended 
that the device be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies devices 
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 device 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 norovirus serological 
reagents, and this device type is identified as devices that consist of 
antigens and antisera used in serological tests to detect the presence 
of norovirus antigens in fecal samples. These devices aid in the 
diagnosis of norovirus infection in the setting of an individual 
patient with symptoms of acute gastroenteritis when the individual 
patient is epidemiologically linked to other patients with symptoms of 
acute gastroenteritis and/or aid in the identification of norovirus as 
the etiology of an outbreak of acute gastroenteritis in the setting of 
epidemiologically linked patients with symptoms of acute 
gastroenteritis.

III. Risks to Health

    FDA has identified the risks to health associated with this type of 
device as a false negative result and a false positive result. A false 
positive test result for an individual may lead to a potential delay in 
needed antibiotic treatment (when appropriate) and possibly less 
thorough laboratory evaluation for the true cause of illness; in the 
setting of an outbreak investigation, a false positive result may lead 
to unnecessary environmental interventions and/or significant patient 
restrictions. A false negative test result for an individual may lead 
to potentially unnecessary treatment for other causes of acute 
gastroenteritis, including possible antibiotic exposure; in the setting 
of an outbreak, a false negative result may lead to delay in 
recognizing the cause of the outbreak and additional spread of 
norovirus infection.
    FDA has identified the following recommended mitigation measures to 
address these risks to health associated specifically with this type of 
device.

                          Table 1--Risks to Health and Recommended Mitigation Measures
----------------------------------------------------------------------------------------------------------------
              Identified risks                                  Recommended mitigation measures
----------------------------------------------------------------------------------------------------------------
A false positive test result for an           Performance Characteristics Labeling.
 individual may lead to a potential delay in
 needed antibiotic treatment (when
 appropriate) and possibly less thorough
 laboratory evaluation for the true cause of
 illness; in the setting of an outbreak
 investigation, a false positive result may
 lead to unnecessary environmental
 interventions and/or significant patient
 restrictions.
A false negative test result for an           Performance Characteristics Labeling.
 individual may lead to potentially
 unnecessary treatment for other causes of
 acute gastroenteritis, including possible
 antibiotic exposure; in the setting of an
 outbreak, a false negative result may lead
 to delay in recognizing the cause of the
 outbreak and additional spread of norovirus
 infection.
----------------------------------------------------------------------------------------------------------------

    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. FDA believes that the special controls 
guidance document, in addition to general controls, addresses the risks 
to health identified previously and provides reasonable assurance of 
the safety and effectiveness of the device. Therefore, on February 23, 
2011, FDA issued an order to the petitioner classifying the device into 
class II. FDA is codifying this device by adding Sec.  866.3395.

IV. 510(k) Premarket Notification

    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for a norovirus 
serological reagents 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 FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k), if FDA determines that premarket notification is not necessary 
to provide

[[Page 14274]]

reasonable assurance of the safety and effectiveness of the device. For 
this type of device, FDA has determined because of the risks of false 
positives and false negatives that premarket notification is necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device and, therefore, 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, prior to marketing 
the device, which contains information about the norovirus serological 
reagents they intend to market.

V. Environmental Impact

    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.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act 
(Pub. L. 96-354) (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 
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 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule is deregulatory and imposes no new 
burdens, the Agency proposes to certify 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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive Order 
requires Agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain state requirements ``different or in addition 
to'' certain federal requirements applicable to devices. 21 U.S.C. 
360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, 
Inc., 552 U.S. 312 (2008). The special controls established by this 
rulemaking create ``requirements'' to address each identified risk to 
health presented by these specific medical devices under 21 U.S.C. 
360k, even though product sponsors may have flexibility in how they 
meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 
740-42 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    This final rule establishes as special controls a guidance document 
that refers to previously approved collections of information found in 
other FDA regulations. These collections of information are subject to 
review by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). 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: Norovirus Serological Reagents.'' The 
notice contains an analysis of the paperwork burden for the guidance.

IX. References

    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 R-Biopharm AG, c/o Lehnus and Associates, dated 
February 15, 2011.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    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 866.3395 is added to subpart D to read as follows:


Sec.  866.3395  Norovirus serological reagents.

    (a) Identification. Norovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to detect 
the presence of norovirus antigens in fecal samples. These devices aid 
in the diagnosis of norovirus infection in the setting of an individual 
patient with symptoms of acute gastroenteritis when the individual 
patient is epidemiologically linked to other patients with symptoms of 
acute gastroenteritis and/or aid in the identification of norovirus as 
the etiology of an outbreak of acute gastroenteritis in the setting of 
epidemiologically linked patients with symptoms of acute 
gastroenteritis.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Norovirus Serological Reagents.'' See Sec.  866.1(e) 
for the availability of this guidance document.

    Dated: March 5, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-5675 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P