[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Rules and Regulations]
[Pages 3739-3740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2013-N-1662]


Medical Devices; Immunology and Microbiology Devices; 
Classification of John Cunningham Virus Serological Reagents

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying John 
Cunningham Virus (JCV) serological reagents into class II (special 
controls). 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.

DATES: This order is effective February 24, 2014. The classification 
was effective January 20, 2012.

FOR FURTHER INFORMATION CONTACT: Haja Sittana El Mubarak, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 5519, Silver Spring, MD 20993-0002, 
301-796-6193.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the 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), 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 predicate 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 the regulations.
    Section 513(f)(2) of the FD&C Act provided a procedure by which a 
person may request that FDA classify a device under the criteria set 
forth in section 513(a)(1). The person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
In response to a request to classify a device under the procedure 
provided by section 513(f)(2) of the FD&C Act, FDA will classify the 
device by written order within 60 days. This classification will 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 this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on December 22, 2011, classifying the STRATIFY JCVTM 
antibody enzyme-linked immunosorbent assay (ELISA) 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 which was 
subsequently reclassified into class I or class II. On January 5, 2012, 
Focus Diagnostics, Inc., submitted a request for de novo classification 
of the STRATIFY JCVTM antibody ELISA under section 513(f)(2) 
of the FD&C Act. The manufacturer recommended that the device be 
classified into class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request for de novo classification in order to classify the device 
under the criteria for classification set forth in section 513(a)(1) of 
the FD&C Act. 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 request, 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 John Cunningham Virus 
serological reagents, which are devices that consist of antigens and 
antisera used in serological assays to identify antibodies to JCV in 
serum and plasma. The identification aids in the risk stratification 
for the development of progressive multifocal leukoencephalopathy in 
multiple sclerosis and Crohn's disease patients undergoing natalizumab 
therapy. These devices are for adjunctive use, in the context of other 
clinical risk factors for the development of progressive multifocal 
leukoencephalopathy.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

       Table 1--Identified Risks to Health and Mitigation Measures
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        Identified risks to health               Mitigation measures
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False positive results....................  Device Description
                                            Performance.
False negative results....................  Device Description
                                            Performance.

[[Page 3740]]

 
Failure to perform as indicated or an       Labeling.
 error in the interpretation of the
 results.
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    FDA believes that the measures set forth in the special controls 
guideline entitled ``Class II Special Controls Guideline: John 
Cunningham Virus Serological Reagents'' are necessary, in addition to 
general controls, to mitigate the risks to health described in table 1.
    Therefore, on January 20, 2012, FDA issued an order to the 
petitioner classifying JCV serological reagents into class II. FDA is 
codifying this device type by adding 21 CFR 866.3336.

II. 510(k) Premarket Notification

    Following the effective date of this final classification order, 
any firm submitting a 510(k) premarket notification for this device 
type will need to comply with the special controls.
    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) of the FD&C 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. 
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 JCV serological 
reagents they intend to market.

III. 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.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer 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 (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120; and 
the collections of information in 21 CFR part 801 and 21 CFR 809.10 
have been approved under OMB control number 0910-0485.

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 866.3336 is added to subpart D to read as follows:


Sec.  866.3336  John Cunningham Virus serological reagents.

    (a) Identification. John Cunningham Virus serological reagents are 
devices that consist of antigens and antisera used in serological 
assays to identify antibodies to John Cunningham Virus in serum and 
plasma. The identification aids in the risk stratification for the 
development of progressive multifocal leukoencephalopathy in multiple 
sclerosis and Crohn's disease patients undergoing natalizumab therapy. 
These devices are for adjunctive use, in the context of other clinical 
risk factors for the development of progressive multifocal 
leukoencephalopathy.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guideline document entitled ``Class 
II Special Controls Guideline: John Cunningham Virus Serological 
Reagents.'' For availability of the guideline document, see Sec.  
866.1(e).

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01216 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P