[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67313-67314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27817]
[[Page 67313]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2015-N-3392]
Medical Devices; Immunology and Microbiology Devices;
Classification of Gastrointestinal Microorganism Multiplex Nucleic
Acid-Based Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying a
gastrointestinal microorganism multiplex nucleic acid-based assay 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 November 2, 2015. The classification was
applicable January 14, 2013.
FOR FURTHER INFORMATION CONTACT: Andrew Grove, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198.
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), 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) of the FD&C Act 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.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on January 03, 2013 automatically classifying the xTAG[supreg]
Gastrointestinal Pathogen Panel (GPP) in 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, nor to a device that was subsequently reclassified
into class I or class II. On January 10, 2013, Luminex Molecular
Diagnostics, submitted a request for de novo classification of the
xTAG[supreg] GPP under section 513(f)(2) of the FD&C Act.
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.
Therefore, on January 14, 2013, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3990 (Sec.
866.3990).
Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a gastrointestinal microorganism multiplex nucleic acid-
based assay will need to comply with the special controls named in this
final administrative order.
The device is assigned the generic name gastrointestinal
microorganism multiplex nucleic acid-based assay, and it is identified
as a qualitative in vitro diagnostic device intended to simultaneously
detect and identify multiple gastrointestinal microbial nucleic acids
extracted from human stool specimens. The device detects specific
nucleic acid sequences for organism identification as well as for
determining the presence of toxin genes. The detection and
identification of a specific gastrointestinal microbial nucleic acid
from individuals exhibiting signs and symptoms of gastrointestinal
infection aids in the diagnosis of gastrointestinal infection when used
in conjunction with clinical evaluation and other laboratory findings.
A gastrointestinal microorganism multiplex nucleic acid-based assay
also aids in the detection and identification of acute gastroenteritis
in the context of outbreaks.
FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:
[[Page 67314]]
Table 1--Identified Risks and Required Mitigations
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Failure of the device to detect and The FDA document entitled
identify a targeted organism when such ``Class II Special Controls
organism is present in the specimen Guideline: Gastrointestinal
(i.e., false negative result for Microorganism Multiplex
presence of organism). Nucleic Acid-Based Assays for
Detection and Identification
of Microorganisms and Toxin
Genes from Human Stool
Specimens,'' which addresses
this risk through: Specific
device description
requirements, performance
studies, and labeling.
Detection of the targeted microorganism The FDA document entitled
when such organism is not present in ``Class II Special Controls
the specimen (i.e., false positive Guideline: Gastrointestinal
result for presence of organism). Microorganism Multiplex
Nucleic Acid-Based Assays for
Detection and Identification
of Microorganisms and Toxin
Genes from Human Stool
Specimens,'' which addresses
this risk through: Specific
device description
requirements, performance
studies, and labeling.
Failure to correctly interpret test The FDA document entitled
results. ``Class II Special Controls
Guideline: Gastrointestinal
Microorganism Multiplex
Nucleic Acid-Based Assays for
Detection and Identification
of Microorganisms and Toxin
Genes from Human Stool
Specimens,'' which addresses
this risk through: Specific
device description
requirements and labeling.
------------------------------------------------------------------------
FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline:
Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for
Detection and Identification of Microorganisms and Toxin Genes from
Human Stool Specimens'' are necessary, in addition to general controls,
to mitigate the risks to health described in table 1.
II. Premarket Notification
A gastrointestinal microorganism multiplex nucleic acid-based assay
is a prescription device. 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 gastrointestinal
microorganism multiplex nucleic acid-based assay they intend to market.
III. Environmental Impact
We have 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 21 CFR 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 regarding
quality systems have been approved under OMB control number 0910-0073;
and the collections of information in 21 CFR parts 801 and 809
regarding labeling 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 part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 866.3990 to subpart D to read as follows:
Sec. 866.3990 Gastrointestinal microorganism multiplex nucleic acid-
based assay.
(a) Identification. A gastrointestinal microorganism multiplex
nucleic acid-based assay is a qualitative in vitro diagnostic device
intended to simultaneously detect and identify multiple
gastrointestinal microbial nucleic acids extracted from human stool
specimens. The device detects specific nucleic acid sequences for
organism identification as well as for determining the presence of
toxin genes. The detection and identification of a specific
gastrointestinal microbial nucleic acid from individuals exhibiting
signs and symptoms of gastrointestinal infection aids in the diagnosis
of gastrointestinal infection when used in conjunction with clinical
evaluation and other laboratory findings. A gastrointestinal
microorganism multiplex nucleic acid-based assay also aids in the
detection and identification of acute gastroenteritis in the context of
outbreaks.
(b) Classification. Class II (special controls). The special
controls are set forth in FDA's guideline document entitled: ``Class II
Special Controls Guideline: Gastrointestinal Microorganism Multiplex
Nucleic Acid-Based Assays for Detection and Identification of
Microorganisms and Toxin Genes from Human Stool Specimens.'' For
availability of the guideline document, see Sec. 866.1(e).
Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27817 Filed 10-30-15; 8:45 am]
BILLING CODE 4164-01-P