[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Rules and Regulations]
[Pages 31021-31023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-0429]


Medical Devices; Immunology and Microbiology Devices; 
Classification of Dengue 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 dengue 
virus serological reagents into class II (special controls). The 
special controls that will apply to the device are identified in this 
order, and the codified language for the dengue serological reagents 
classification will include the identification of the special controls 
that will apply to this device. The Agency is classifying the device 
into class II (special controls) because special controls, in addition 
to general controls, will provide a reasonable assurance of safety and 
effectiveness of the device.

DATES: This order is effective June 30, 2014. The classification was 
applicable April 8, 2011.

FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993-0002, 301-796-6202.

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

[[Page 31022]]

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, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012), provides two procedures by which a person may 
request FDA to classify a device under the criteria set forth in 
section 513(a)(1). Under the first procedure, 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). Under the second procedure, rather than first 
submitting a premarket notification under section 510(k) and then a 
request for classification under the first procedure, the person 
determines that there is no legally marketed device upon which to base 
a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act. If the person 
submits a request to classify the device under this second procedure, 
FDA may decline to undertake the classification request if FDA 
identifies a legally marketed device that could provide a reasonable 
basis for review of substantial equivalence with the device or if FDA 
determines that the device submitted is not of ``low-moderate risk'' or 
that general controls would be inadequate to control the risks and 
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 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 October 8, 2010, classifying the InBios DENV Detect IgM 
Capture 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 October 20, 2010, InBios International 
Inc., submitted a request for de novo classification of the InBios DENV 
Detect IgM Capture 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 dengue virus serological 
reagents, which are identified as devices that consist of antigens and 
antibodies for the detection of dengue virus and dengue antibodies in 
individuals who have signs and symptoms of dengue fever or dengue 
hemorrhagic fever. The detection aids in the clinical laboratory 
diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue 
virus.
    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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A false positive test result for an      Device Description Containing
 individual may lead to unnecessary       the Information Specified in
 treatment and possibly a less thorough   the Special Control Guideline.
 laboratory evaluation for the true      Performance Characteristics.
 cause of illness; a false positive      Labeling.
 result may lead to unnecessary          Postmarket Measures.
 initiation of mosquito vector control
 measures.
A false negative test result may lead    Device Description Containing
 to inappropriate use of antibiotics or   the Information Specified in
 a delay in treatment to prevent death    the Special Control Guideline.
 due to dengue hemorrhagic fever or      Performance Characteristics.
 dengue shock syndrome or a false        Labeling.
 negative result may lead to delay in    Postmarket Measures.
 initiation of mosquito vector control
 measures.
An error in the interpretation of the    Labeling.
 results.
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    FDA believes that the measures set forth in the special controls 
guideline entitled ``Class II Special Controls Guideline: Dengue Virus 
Serological Reagents'' are necessary, in addition to general controls, 
to mitigate the risks to health described in table 1.
    Therefore, on April 8, 2011, FDA issued an order to the petitioner 
classifying dengue virus serological reagents into class II. FDA is 
codifying this device type by adding Sec.  866.3945).
    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

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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 dengue virus nucleic acid amplification test reagents they 
intend to market.

II. 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.

III. 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; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; 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 866.3945 is added to subpart D to read as follows:


Sec.  866.3945  Dengue virus serological reagents.

    (a) Identification. Dengue virus serological reagents are devices 
that consist of antigens and antibodies for the detection of dengue 
virus and dengue antibodies in individuals who have signs and symptoms 
of dengue fever or dengue hemorrhagic fever. The detection aids in the 
clinical laboratory diagnosis of dengue fever or dengue hemorrhagic 
fever caused by dengue virus.
    (b) Classification. Class II (special controls). The special 
control is FDA's guideline entitled ``Class II Special Controls 
Guideline: Dengue Virus Serological Reagents.'' For availability of the 
guideline document, see Sec.  866.1(e).

    Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12545 Filed 5-29-14; 8:45 am]
BILLING CODE 4160-01-P