Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay, 51938-51939 [2015-21237]
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51938
Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2015–N–2963]
Medical Devices; Immunology and
Microbiology Devices; Classification of
Clostridium Difficile Toxin Gene
Amplification Assay
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying
Clostridium difficile (C. difficile) toxin
gene amplification 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 September
28, 2015. The classification was
applicable April 30, 2012.
FOR FURTHER INFORMATION CONTACT: Noel
Gerald, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5566, Silver Spring,
MD 20993–0002, 301–796–4695.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 ‘‘lowmoderate 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
February 3, 2012, automatically
classifying the Portrait Toxigenic C.
difficile Assay in class III, because it was
not within a type of device which was
introduced or delivered for introduction
into interstate commerce for commercial
distribution before May 28, 1976, nor
which was subsequently reclassified
into class I or class II. On March 2, 2012,
Great Basin Scientific, Inc., submitted a
request for de novo classification of the
Portrait Toxigenic C. difficile Assay
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). 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 April 30, 2012, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding § 866.3130.
Following the effective date of this
final classification administrative order,
any firm submitting a premarket
notification (510(k)) for a C. difficile
toxin gene amplification assay will need
to comply with the special controls
named in the final administrative order.
The device is assigned the generic
name C. difficile toxin gene
amplification assay, and it is identified
as a device that consists of reagents for
the amplification and detection of target
sequences in C. difficile toxin genes in
fecal specimens from patients suspected
of having a C. difficile infection (CDI).
The detection of clostridial toxin genes,
in conjunction with other laboratory
tests, aids in the clinical laboratory
diagnosis of CDI caused by C. difficile.
FDA has identified the following risks
to health associated with this type of
device and the measures required to
mitigate these risks:
rmajette on DSK2VPTVN1PROD with RULES
TABLE 1—IDENTIFIED RISKS AND REQUIRED MITIGATIONS
Identified risks
Required mitigations
A false positive test result for an individual may lead to inappropriate
use of antibiotics for treatment.
The FDA document entitled ‘‘Class II Special Controls Guideline: Toxin
Gene Amplification Assays for the Detection of Clostridium difficile,’’
which addresses this risk through:
Specific Device Description Requirements.
Performance Studies.
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Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Rules and Regulations
51939
TABLE 1—IDENTIFIED RISKS AND REQUIRED MITIGATIONS—Continued
Identified risks
Required mitigations
A false negative test result for an individual may lead to a potential
delay in treatment.
Failure of the test to be used or perform properly ...................................
Failure to properly interpret the test results .............................................
FDA believes that the measures set
forth in the special controls guideline
entitled ‘‘Class II Special Controls
Guideline: Toxin Gene Amplification
Assays for the Detection of Clostridium
difficile’’ are necessary, in addition to
general controls, to mitigate the risks to
health described in table 1.
A C. difficile toxin gene amplification
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) 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 C. difficile toxin
gene amplification assay they intend to
market.
rmajette on DSK2VPTVN1PROD with RULES
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
VerDate Sep<11>2014
14:03 Aug 26, 2015
Jkt 235001
Labeling.
The FDA document entitled ‘‘Class II Special Controls Guideline: Toxin
Gene Amplification Assays for the Detection of Clostridium difficile,’’
which addresses this risk through:
Specific Device Description Requirements.
Performance Studies.
Labeling.
The FDA document entitled ‘‘Class II Special Controls Guideline: Toxin
Gene Amplification Assays for the Detection of Clostridium difficile,’’
which addresses this risk through:
Labeling.
The FDA document entitled ‘‘Class II Special Controls Guideline: Toxin
Gene Amplification Assays for the Detection of Clostridium difficile,’’
which addresses this risk through:
Labeling.
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 parts 801 and
809 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:
(b) Classification. Class II (special
controls). The special controls are set
forth in FDA’s guideline document
entitled: ‘‘Class II Special Controls
Guideline: Toxin Gene Amplification
Assays for the Detection of Clostridium
difficile; Guideline for Industry and
Food and Drug Administration Staff.’’
See § 866.1(e) for information on
obtaining this document.
Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21237 Filed 8–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9731]
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
RIN 1545–BM11
■
1. The authority citation for 21 CFR
part 866 continues to read as follows:
Allocation of W–2 Wages in a Short
Taxable Year and in an Acquisition or
Disposition
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
AGENCY:
2. Add § 866.3130 to subpart D to read
as follows:
■
§ 866.3130 Clostridium difficile toxin gene
amplification assay.
(a) Identification. A Clostridium
difficile toxin gene amplification assay
is a device that consists of reagents for
the amplification and detection of target
sequences in Clostridium difficile toxin
genes in fecal specimens from patients
suspected of having Clostridium difficile
infection (CDI). The detection of
clostridial toxin genes, in conjunction
with other laboratory tests, aids in the
clinical laboratory diagnosis of CDI
caused by Clostridium difficile.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
This document contains final
and temporary regulations relating to
the allocation of W–2 wages for
purposes of the W–2 wage limitation on
the amount of a taxpayer’s deduction
related to domestic production
activities. Specifically, the temporary
regulations provide guidance on: the
allocation of W–2 wages paid by two or
more taxpayers that are employers of the
same employees during a calendar year;
and the determination of W–2 wages if
the taxpayer has a short taxable year.
The text of the temporary regulations
SUMMARY:
E:\FR\FM\27AUR1.SGM
27AUR1
Agencies
[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Rules and Regulations]
[Pages 51938-51939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21237]
[[Page 51938]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2015-N-2963]
Medical Devices; Immunology and Microbiology Devices;
Classification of Clostridium Difficile Toxin Gene Amplification Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying
Clostridium difficile (C. difficile) toxin gene amplification 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 September 28, 2015. The classification
was applicable April 30, 2012.
FOR FURTHER INFORMATION CONTACT: Noel Gerald, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5566, Silver Spring, MD 20993-0002, 301-796-4695.
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 February 3, 2012, automatically classifying the Portrait
Toxigenic C. difficile Assay in class III, because it was not within a
type of device which was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976,
nor which was subsequently reclassified into class I or class II. On
March 2, 2012, Great Basin Scientific, Inc., submitted a request for de
novo classification of the Portrait Toxigenic C. difficile Assay 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).
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 April 30, 2012, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec. 866.3130.
Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a C. difficile toxin gene amplification assay will need to
comply with the special controls named in the final administrative
order.
The device is assigned the generic name C. difficile toxin gene
amplification assay, and it is identified as a device that consists of
reagents for the amplification and detection of target sequences in C.
difficile toxin genes in fecal specimens from patients suspected of
having a C. difficile infection (CDI). The detection of clostridial
toxin genes, in conjunction with other laboratory tests, aids in the
clinical laboratory diagnosis of CDI caused by C. difficile.
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 and Required Mitigations
------------------------------------------------------------------------
Identified risks Required mitigations
------------------------------------------------------------------------
A false positive test result for an The FDA document entitled
individual may lead to inappropriate ``Class II Special Controls
use of antibiotics for treatment. Guideline: Toxin Gene
Amplification Assays for the
Detection of Clostridium
difficile,'' which addresses
this risk through:
Specific Device Description
Requirements.
Performance Studies.
[[Page 51939]]
Labeling.
A false negative test result for an The FDA document entitled
individual may lead to a potential ``Class II Special Controls
delay in treatment. Guideline: Toxin Gene
Amplification Assays for the
Detection of Clostridium
difficile,'' which addresses
this risk through:
Specific Device Description
Requirements.
Performance Studies.
Labeling.
Failure of the test to be used or The FDA document entitled
perform properly. ``Class II Special Controls
Guideline: Toxin Gene
Amplification Assays for the
Detection of Clostridium
difficile,'' which addresses
this risk through:
Labeling.
Failure to properly interpret the test The FDA document entitled
results. ``Class II Special Controls
Guideline: Toxin Gene
Amplification Assays for the
Detection of Clostridium
difficile,'' which addresses
this risk through:
Labeling.
------------------------------------------------------------------------
FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline: Toxin Gene
Amplification Assays for the Detection of Clostridium difficile'' are
necessary, in addition to general controls, to mitigate the risks to
health described in table 1.
A C. difficile toxin gene amplification 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) 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 C. difficile toxin
gene amplification assay 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 parts 801 and 809 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. Add Sec. 866.3130 to subpart D to read as follows:
Sec. 866.3130 Clostridium difficile toxin gene amplification assay.
(a) Identification. A Clostridium difficile toxin gene
amplification assay is a device that consists of reagents for the
amplification and detection of target sequences in Clostridium
difficile toxin genes in fecal specimens from patients suspected of
having Clostridium difficile infection (CDI). The detection of
clostridial toxin genes, in conjunction with other laboratory tests,
aids in the clinical laboratory diagnosis of CDI caused by Clostridium
difficile.
(b) Classification. Class II (special controls). The special
controls are set forth in FDA's guideline document entitled: ``Class II
Special Controls Guideline: Toxin Gene Amplification Assays for the
Detection of Clostridium difficile; Guideline for Industry and Food and
Drug Administration Staff.'' See Sec. 866.1(e) for information on
obtaining this document.
Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21237 Filed 8-26-15; 8:45 am]
BILLING CODE 4164-01-P