
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34848-34850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-1917]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the Assayed Quality Control Material for Clinical 
Microbiology Assays

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the assayed quality control material for clinical 
microbiology assays into class II (special controls). The special 
controls that will apply to the device are identified in this order and 
will be part of the codified language for the assayed quality control 
material for clinical microbiology assays' classification. The Agency 
is classifying the device into class II (special controls) to provide a 
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective July 27, 2017. The classification was 
applicable on March 28, 2016.

[[Page 34849]]


FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, 
ryan.lubert@fda.hhs.gov.

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, also known as De Novo 
classification, 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On December 18, 2015, Bio-Rad Laboratories, Inc., submitted a 
request for classification of the Amplichek II 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 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, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on March 28, 2016, 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 866.3920.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an assayed 
quality control material for clinical microbiology assays will need to 
comply with the special controls named in this final order. A De Novo 
classification decreases regulatory burdens. When FDA classifies a 
device type as class I or II via the De Novo pathway, other 
manufacturers do not have to submit a De Novo request or premarket 
approval application to market the same type of device, unless the 
device has a new intended use or technological characteristics that 
raise different questions of safety or effectiveness. Instead, 
manufacturers can use the less burdensome pathway of 510(k), when 
necessary, to market their device, and the device that was the subject 
of the original De Novo classification can serve as a predicate device 
for additional 510(k)s from other manufacturers.
    The device is assigned the generic name assayed quality control 
material for clinical microbiology assays, and it is identified as a 
device indicated for use in a test system to estimate test precision or 
to detect systematic analytical deviations that may arise from reagent 
or analytical instrument variation. This type of device consists of 
single or multiple microbiological analytes intended for use with 
either qualitative or quantitative assays.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1:

   Table 1--Assayed Quality Control Material for Clinical Microbiology
                  Assays Risks and Mitigation Measures
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      Identified risks to health              Required mitigations
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Incorrect use of the instrument for     Special Control (1) (21 CFR
 non-indicated samples resulting in a    866.3920(b)(1)); Special
 delay in diagnosis.                     Control (3) (21 CFR
                                         866.3920(b)(3)); and Special
                                         Control (4) (21 CFR
                                         866.3920(b)(4)).
Assessment performance error (false     Special Control (1) (21 CFR
 negative).                              866.3920(b)(1)).
Incorrect results due to improper or    Special Control (2) (21 CFR
 unexpected performance.                 866.3920(b)(2)) and Special
                                         Control (4)(iii) (21 CFR
                                         866.3920(b)(4)(iii)).
Failure to correctly operate the        Special Control (1) (21 CFR
 instrument.                             866.3920(b)(1)).
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    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. This device type is not exempt 
from premarket notification

[[Page 34850]]

requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification (510(k)), prior to marketing the 
device, which contains information about the assayed quality control 
material for clinical microbiology assays they intend to market.

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
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 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, 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 is revised to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  866.3920 to subpart D to read as follows:


Sec.  866.3920  Assayed quality control material for clinical 
microbiology assays.

    (a) Identification. An assayed quality control material for 
clinical microbiology assays is a device indicated for use in a test 
system to estimate test precision or to detect systematic analytical 
deviations that may arise from reagent or analytical instrument 
variation. This type of device consists of single or multiple 
microbiological analytes intended for use with either qualitative or 
quantitative assays.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed device 
description documentation and information concerning the composition of 
the quality control material, including, as appropriate:
    (i) Analyte concentration;
    (ii) Expected values;
    (iii) Analyte source;
    (iv) Base matrix;
    (v) Added components;
    (vi) Safety and handling information; and
    (vii) Detailed instructions for use.
    (2) Premarket notification submissions must include detailed 
documentation, including line data as well as detailed study protocols 
and a statistical analysis plan used to establish performance, 
including:
    (i) Description of the process for value assignment and validation.
    (ii) Description of the protocol(s) used to establish stability.
    (iii) Line data establishing precision/reproducibility.
    (iv) Where applicable, assessment of matrix effects and any 
significant differences between the quality control material and 
typical patient samples in terms of conditions known to cause 
analytical error or affect assay performance.
    (v) Where applicable, identify or define traceability or 
relationship to a domestic or international standard reference material 
and/or method.
    (vi) Where applicable, detailed documentation related to studies 
for surrogate controls.
    (3) Premarket notification submissions must include an adequate 
mitigation (e.g., real-time stability program) to the risk of false 
results due to potential modifications to the assays specified in the 
device's 21 CFR 809.10 compliant labeling.
    (4) Your 21 CFR 809.10 compliant labeling must include the 
following:
    (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) 
compliant labeling must include the following:
    (A) Assayed control material analyte(s);
    (B) Whether the material is intended for quantitative or 
qualitative assays;
    (C) Stating if the material is a surrogate control; and
    (D) The system(s), instrument(s), or test(s) for which the quality 
control material is intended.
    (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) 
compliant labeling must include the following statement: ``This product 
is not intended to replace manufacturer controls provided with the 
device.''
    (iii) A limiting statement that reads ``Quality control materials 
should be used in accordance with local, state, federal regulations, 
and accreditation requirements.''

    Dated: July 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15858 Filed 7-26-17; 8:45 am]
BILLING CODE 4164-01-P


