Document ID: FDA-2014-N-1166-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents
Posted Date: 2014-09-10T04:00Z

[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Rules and Regulations]
[Pages 53608-53609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-1166]

Medical Devices; Immunology and Microbiology Devices; 
Classification of Dengue Virus Nucleic Acid Amplification Test 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 nucleic acid amplification test reagents into class II (special 
controls). 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 October 10, 2014. The classification was 
applicable May 24, 2012.

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 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, 126 Statute 1054), 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 February 24, 2012, classifying the CDC DENV-1-4 Real-Time RT-
PCR Assay 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 March 12, 2012, the Centers for Disease Control and Prevention 
submitted a request for de novo classification of the CDC DENV-1-4 
Real-Time RT-PCR Assay 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 nucleic acid 
amplification test reagents, and it is identified as devices that 
consist of primers, probes, enzymes, and controls for the amplification 
and detection of dengue virus serotypes 1, 2, 3, or 4 from viral 
ribonucleic acid (RNA) in human serum and plasma from individuals who 
have signs and symptoms consistent with dengue (mild or severe). The 
identification of dengue virus serotypes 1, 2, 3, or 4 in human serum 
and plasma (sodium citrate) collected from human

[[Page 53609]]

patients with dengue provides epidemiologic information for 
surveillance of circulating dengue viruses.
    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 
Nucleic Acid Amplification Test Reagents'' are necessary, in addition 
to general controls, to mitigate the risks to health described in table 
1.
    Therefore, on May 24, 2012, FDA issued an order to the petitioner 
classifying dengue virus nucleic acid amplification test reagents into 
class II. FDA is codifying this device type by adding Sec.  866.3946.

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 dengue virus nucleic 
acid amplification test 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; 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 866.3946 is added to subpart D to read as follows:

Sec.  866.3946  Dengue virus nucleic acid amplification test reagents.

    (a) Identification. Dengue virus nucleic acid amplification test 
reagents are devices that consist of primers, probes, enzymes, and 
controls for the amplification and detection of dengue virus serotypes 
1, 2, 3, or 4 from viral ribonucleic acid (RNA) in human serum and 
plasma from individuals who have signs and symptoms consistent with 
dengue (mild or severe). The identification of dengue virus serotypes 
1, 2, 3, or 4 in human serum and plasma (sodium citrate) collected from 
human patients with dengue provides epidemiologic information for 
surveillance of circulating dengue viruses.
    (b) Classification. Class II (special controls). The special 
control is FDA's guideline entitled ``Class II Special Controls 
Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents.'' For 
availability of the guideline document, see Sec.  866.1(e).

    Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21479 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P