[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]]

=======================================================================
-----------------------------------------------------------------------

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