[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
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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