80 FR 46190 - Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

Page Range		46190-46192
FR Document		2015-19072

The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid 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.

Federal Register, Volume 80 Issue 149 (Tuesday, August 4, 2015)

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Rules and Regulations]
[Pages 46190-46192]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19072]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2015-N-2526]


Medical Devices; Immunology and Microbiology Devices; 
Classification of  Trichomonas Vaginalis Nucleic Acid Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying a 
Trichomonas vaginalis nucleic acid 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 August 4, 2015. The classification was 
applicable April 19, 2011.

FOR FURTHER INFORMATION CONTACT: Himani Bisht, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5565, Silver Spring, MD 20993-0002, 301-796-6189.

SUPPLEMENTARY INFORMATION:

[[Page 46191]]

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 April 12, 2011, automatically classifying the APTIMA 
Trichomonas vaginalis 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 
April 13, 2011, Gen-Probe Incorporated, submitted a request for de novo 
classification of the APTIMA Trichomonas vaginalis 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) 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 April 19, 2011, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  866.3860.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a Trichomonas vaginalis nucleic acid assay will need to 
comply with the special controls named in the final administrative 
order.
    The device is assigned the generic name Trichomonas vaginalis 
nucleic acid assay, and it is identified as a device that consists of 
primers, probes, enzymes, and controls for the amplification and 
detection of trichomonas nucleic acids in endocervical swabs, vaginal 
swabs, and female urine specimens, from women symptomatic for 
vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of 
trichomoniasis in asymptomatic women. The detection of trichomonas 
nucleic acids, in conjunction with other laboratory tests, aids in the 
clinical laboratory diagnosis of trichomoniasis caused by Trichomonas 
vaginalis.
    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 may lead    The FDA document entitled ``Class II Special Controls Guideline:
 to inappropriate use of antibiotics      Nucleic Acid Amplification Assays for the Detection of Trichomonas
 for treatment.                           vaginalis'', which addresses this risk through: Specific device
                                          description requirements, performance studies, and labeling.
A false negative test result for an      The FDA document entitled ``Class II Special Controls Guideline:
 individual may lead to a potential       Trichomonas vaginalis Nucleic Acid Amplification Test System'', which
 delay in treatment.                      addresses this risk through: Specific device description requirements,
                                          performance studies, and labeling.
Failure of the test to perform properly  The FDA document entitled ``Class II Special Controls Guideline:
                                          Nucleic Acid Amplification Assays for the Detection of Trichomonas
                                          Vaginalis'', which addresses this risk through: Labeling.
Failure to properly interpret the test   The FDA document entitled ``Class II Special Controls Guideline:
 results.                                 Nucleic Acid Amplification Assays for the Detection of Trichomonas
                                          Vaginalis'', which addresses this risk through: Labeling
----------------------------------------------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls 
guideline entitled ``Class II Special Controls Guideline: Nucleic Acid 
Amplification Assays for the Detection of Trichomonas vaginalis'' are 
necessary, in addition to general controls, to mitigate the risks to 
health described in table 1.
    A Trichomonas vaginalis nucleic acid assay is a prescription 
device. Section

[[Page 46192]]

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 Trichomonas vaginalis 
nucleic acid 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.  866.3860 to subpart D to read as follows:


Sec.  866.3860  Trichomonas vaginalis nucleic acid assay.

    (a) Identification. A Trichomonas vaginalis nucleic acid assay is a 
device that consists of primers, probes, enzymes, and controls for the 
amplification and detection of trichomonas nucleic acids in 
endocervical swabs, vaginal swabs, and female urine specimens, from 
women symptomatic for vaginitis, cervicitis, or urethritis and/or to 
aid in the diagnosis of trichomoniasis in asymptomatic women. The 
detection of trichomonas nucleic acids, in conjunction with other 
laboratory tests, aids in the clinical laboratory diagnosis of 
trichomoniasis caused by Trichomonas vaginalis.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's guideline document entitled: ``Class II 
Special Controls Guideline: Nucleic Acid Amplification Assays for the 
Detection of Trichomonas vaginalis; Guideline for Industry and Food and 
Drug Administration Staff.'' See Sec.  866.1(e) for information on 
obtaining this document.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19072 Filed 8-3-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations 46191

I. Background under the first procedure, the person controls by themselves are insufficient
In accordance with section 513(f)(1) of determines that there is no legally to provide reasonable assurance of
marketed device upon which to base a safety and effectiveness, but there is
the Federal Food, Drug, and Cosmetic
determination of substantial sufficient information to establish
Act (the FD&C Act) (21 U.S.C.
equivalence and requests a classification special controls to provide reasonable
360c(f)(1)), devices that were not in
under section 513(f)(2) of the FD&C Act. assurance of the safety and effectiveness
commercial distribution before May 28,
If the person submits a request to of the device for its intended use. After
1976 (the date of enactment of the
classify the device under this second review of the information submitted in
Medical Device Amendments of 1976),
procedure, FDA may decline to the request, FDA determined that the
generally referred to as postamendments
undertake the classification request if device can be classified into class II
devices, are classified automatically by
FDA identifies a legally marketed device with the establishment of special
statute into class III without any FDA
that could provide a reasonable basis for controls. FDA believes these special
rulemaking process. These devices review of substantial equivalence with
remain in class III and require controls will provide reasonable
the device or if FDA determines that the assurance of the safety and effectiveness
premarket approval, unless and until device submitted is not of ‘‘low-
the device is classified or reclassified of the device.
moderate risk’’ or that general controls Therefore, on April 19, 2011, FDA
into class I or II, or FDA issues an order would be inadequate to control the risks
finding the device to be substantially issued an order to the requestor
and special controls to mitigate the risks classifying the device into class II. FDA
equivalent, in accordance with section cannot be developed.
513(i) of the FD&C Act, to a predicate is codifying the classification of the
In response to a request to classify a device by adding § 866.3860.
device that does not require premarket device under either procedure provided
approval. The Agency determines Following the effective date of this
by section 513(f)(2) of the FD&C Act,
whether new devices are substantially final classification administrative order,
FDA will classify the device by written
equivalent to predicate devices by any firm submitting a premarket
order within 120 days. This
means of premarket notification notification (510(k)) for a Trichomonas
classification will be the initial
procedures in section 510(k) of the classification of the device. vaginalis nucleic acid assay will need to
FD&C Act (21 U.S.C. 360(k)) and part In accordance with section 513(f)(1) of comply with the special controls named
807 (21 CFR part 807) of the regulations. the FD&C Act, FDA issued an order on in the final administrative order.
Section 513(f)(2) of the FD&C Act, as April 12, 2011, automatically classifying The device is assigned the generic
amended by section 607 of the Food and the APTIMA Trichomonas vaginalis name Trichomonas vaginalis nucleic
Drug Administration Safety and Assay in class III, because it was not acid assay, and it is identified as a
Innovation Act (Pub. L. 112–144), within a type of device which was device that consists of primers, probes,
provides two procedures by which a introduced or delivered for introduction enzymes, and controls for the
person may request FDA to classify a into interstate commerce for commercial amplification and detection of
device under the criteria set forth in distribution before May 28, 1976, nor trichomonas nucleic acids in
section 513(a)(1). Under the first which was subsequently reclassified endocervical swabs, vaginal swabs, and
procedure, the person submits a into class I or class II. On April 13, female urine specimens, from women
premarket notification under section 2011, Gen-Probe Incorporated, symptomatic for vaginitis, cervicitis, or
510(k) of the FD&C Act for a device that submitted a request for de novo urethritis and/or to aid in the diagnosis
has not previously been classified and, classification of the APTIMA of trichomoniasis in asymptomatic
within 30 days of receiving an order Trichomonas vaginalis Assay under women. The detection of trichomonas
classifying the device into class III section 513(f)(2) of the FD&C Act. nucleic acids, in conjunction with other
under section 513(f)(1) of the FD&C Act, In accordance with section 513(f)(2) of laboratory tests, aids in the clinical
the person requests a classification the FD&C Act, FDA reviewed the laboratory diagnosis of trichomoniasis
under section 513(f)(2). Under the request for de novo classification in caused by Trichomonas vaginalis.
second procedure, rather than first order to classify the device under the FDA has identified the following risks
submitting a premarket notification criteria for classification set forth in to health associated with this type of
under section 510(k) of the FD&C Act section 513(a)(1) of the FD&C Act. FDA device and the measures required to
and then a request for classification classifies devices into class II if general mitigate these risks:

TABLE 1—IDENTIFIED RISKS AND REQUIRED MITIGATIONS
Identified risks Required mitigations

A false positive test result may lead The FDA document entitled ‘‘Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the
to inappropriate use of antibiotics Detection of Trichomonas vaginalis’’, which addresses this risk through: Specific device description re-
for treatment. quirements, performance studies, and labeling.
A false negative test result for an The FDA document entitled ‘‘Class II Special Controls Guideline: Trichomonas vaginalis Nucleic Acid Am-
individual may lead to a potential plification Test System’’, which addresses this risk through: Specific device description requirements,
delay in treatment. performance studies, and labeling.
Failure of the test to perform prop- The FDA document entitled ‘‘Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the
erly. Detection of Trichomonas Vaginalis’’, which addresses this risk through: Labeling.
Failure to properly interpret the test The FDA document entitled ‘‘Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the
mstockstill on DSK4VPTVN1PROD with RULES

results. Detection of Trichomonas Vaginalis’’, which addresses this risk through: Labeling

FDA believes that the measures set Guideline: Nucleic Acid Amplification general controls, to mitigate the risks to
forth in the special controls guideline Assays for the Detection of Trichomonas health described in table 1.
entitled ‘‘Class II Special Controls vaginalis’’ are necessary, in addition to A Trichomonas vaginalis nucleic acid
assay is a prescription device. Section

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46192 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations

510(m) of the FD&C Act provides that Authority: 21 U.S.C. 351, 360, 360c, 360e, assurance of safety and effectiveness of
FDA may exempt a class II device from 360j, 371. the device.
the premarket notification requirements ■ 2. Add § 866.3860 to subpart D to read DATES: This order is effective August 4,
under section 510(k) of the FD&C Act if as follows: 2015. The classification was applicable
FDA determines that premarket on March 6, 2015.
notification is not necessary to provide § 866.3860 Trichomonas vaginalis nucleic
acid assay. FOR FURTHER INFORMATION CONTACT:
reasonable assurance of the safety and Sunny Park, Center for Devices and
effectiveness of the device. For this type (a) Identification. A Trichomonas
vaginalis nucleic acid assay is a device Radiological Health, Food and Drug
of device, FDA has determined that Administration, 10903 New Hampshire
premarket notification is necessary to that consists of primers, probes,
enzymes, and controls for the Ave., Bldg. 66, Rm. 2432, Silver Spring,
provide reasonable assurance of the MD, 20993–0002, 301–796–7059,
safety and effectiveness of the device. amplification and detection of
trichomonas nucleic acids in sunny.park@fda.hhs.gov.
Therefore, this type of device is not SUPPLEMENTARY INFORMATION:
exempt from premarket notification endocervical swabs, vaginal swabs, and
requirements. Persons who intend to female urine specimens, from women I. Background
market this type of device must submit symptomatic for vaginitis, cervicitis, or
urethritis and/or to aid in the diagnosis In accordance with section 513(f)(1) of
to FDA a premarket notification, prior to the Federal Food, Drug, and Cosmetic
marketing the device, which contains of trichomoniasis in asymptomatic
women. The detection of trichomonas Act (the FD&C Act) (21 U.S.C.
information about the Trichomonas 360c(f)(1)), devices that were not in
vaginalis nucleic acid assay they intend nucleic acids, in conjunction with other
laboratory tests, aids in the clinical commercial distribution before May 28,
to market. 1976 (the date of enactment of the
laboratory diagnosis of trichomoniasis
II. Environmental Impact caused by Trichomonas vaginalis. Medical Device Amendments of 1976),
(b) Classification. Class II (special generally referred to as postamendments
The Agency has determined under 21 devices, are classified automatically by
controls). The special controls are set
CFR 25.34(b) that this action is of type statute into class III without any FDA
forth in FDA’s guideline document
that does not individually or rulemaking process. These devices
entitled: ‘‘Class II Special Controls
cumulatively have a significant effect on remain in class III and require
Guideline: Nucleic Acid Amplification
the human environment. Therefore, premarket approval, unless and until
Assays for the Detection of Trichomonas
neither an environmental assessment the device is classified or reclassified
vaginalis; Guideline for Industry and
nor an environmental impact statement into class I or II, or FDA issues an order
Food and Drug Administration Staff.’’
is required. finding the device to be substantially
See § 866.1(e) for information on
III. Paperwork Reduction Act of 1995 obtaining this document. equivalent, in accordance with section
513(i), to a predicate device that does
This final administrative order Dated: July 30, 2015.
not require premarket approval. The
establishes special controls that refer to Leslie Kux, Agency determines whether new
previously approved collections of Associate Commissioner for Policy. devices are substantially equivalent to
information found in other FDA [FR Doc. 2015–19072 Filed 8–3–15; 8:45 am] predicate devices by means of
regulations. These collections of BILLING CODE 4164–01–P premarket notification procedures in
information are subject to review by the section 510(k) of the FD&C Act (21
Office of Management and Budget U.S.C. 360(k)) and part 807 (21 CFR part
(OMB) under the Paperwork Reduction DEPARTMENT OF HEALTH AND 807) of the regulations.
Act of 1995 (44 U.S.C. 3501–3520). The HUMAN SERVICES Section 513(f)(2) of the FD&C Act, as
collections of information in part 807, amended by section 607 of the Food and
subpart E, regarding premarket Food and Drug Administration
Drug Administration Safety and
notification submissions have been Innovation Act (Pub. L. 112–144),
approved under OMB control number 21 CFR Part 874
provides two procedures by which a
0910–0120; the collections of [Docket No. FDA–2015–N–2525] person may request FDA to classify a
information in 21 CFR part 820 have device under the criteria set forth in
been approved under OMB control Medical Devices; Ear, Nose, and Throat section 513(a)(1). Under the first
number 0910–0073; and the collections Devices; Classification of the External procedure, the person submits a
of information in 21 CFR parts 801 and Upper Esophageal Sphincter premarket notification under section
809 have been approved under OMB Compression Device 510(k) of the FD&C Act for a device that
control number 0910–0485. AGENCY: Food and Drug Administration, has not previously been classified and,
List of Subjects in 21 CFR Part 866 HHS. within 30 days of receiving an order
ACTION: Final order. classifying the device into class III
Biologics, Laboratories, Medical under section 513(f)(1), the person
devices. SUMMARY: The Food and Drug requests a classification under section
Therefore, under the Federal Food, Administration (FDA) is classifying the 513(f)(2) of the FD&C Act. Under the
Drug, and Cosmetic Act and under external upper esophageal sphincter second procedure, rather than first
authority delegated to the Commissioner (UES) compression device into class II submitting a premarket notification
of Food and Drugs, 21 CFR part 866 is (special controls). The special controls under section 510(k) of the FD&C Act
mstockstill on DSK4VPTVN1PROD with RULES

amended as follows: that will apply to the device are and then a request for classification
identified in this order and will be part under the first procedure, the person
PART 866—IMMUNOLOGY AND of the codified language for the external determines that there is no legally
MICROBIOLOGY DEVICES UES compression device’s marketed device upon which to base a
classification. The Agency is classifying determination of substantial
■ 1. The authority citation for 21 CFR the device into class II (special controls) equivalence and requests a classification
part 866 continues to read as follows: in order to provide a reasonable under section 513(f)(2) of the FD&C Act.

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Document Created: 2015-12-18 14:51:04
Document Modified: 2015-12-18 14:51:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective August 4, 2015. The classification was applicable April 19, 2011.
Contact		Himani Bisht, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5565, Silver Spring, MD 20993-0002, 301-796-6189.
FR Citation		80 FR 46190
CFR Associated		Biologics; Laboratories and Medical Devices

80 FR 46190 - Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration