[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Rules and Regulations]
[Pages 48413-48415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-5160]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Organophosphate Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the organophosphate test system into class II (special controls). The 
special controls that apply to the device type are identified in this 
order and will be part of the codified language for the organophosphate 
test system's classification. We are taking this action because we have 
determined that classifying the device into class II (special controls) 
will provide a reasonable assurance of safety and effectiveness of the 
device. We believe this action will also enhance patients' access to 
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 18, 2017. The classification was 
applicable on August 8, 2013.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the organophosphate test system as 
class II (special controls), which we have determined will provide a 
reasonable assurance of safety and effectiveness. In addition, we 
believe this action will enhance patients' access to beneficial 
innovation, in part by reducing regulatory burdens by placing the 
device into a lower device class than the automatic class III 
assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to

[[Page 48414]]

these devices as ``postamendments devices'' because they were not in 
commercial distribution prior to the date of enactment of the Medical 
Device Amendments of 1976, which amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k) and 21 CFR part 807.
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval (PMA) application in order to market a 
substantially equivalent device (see 21 U.S.C. 360c(i), defining 
``substantial equivalence'').
    Instead, sponsors can use the less burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 2, 2013, finding the 
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS 
(liquid chromatography-tandem mass spectrometry (the two ``MS'' next to 
each other denote ``tandem'')) not substantially equivalent to a 
predicate not subject to PMA. Thus, the device remained in class III in 
accordance with section 513(f)(1) of the FD&C Act when we issued the 
order.
    On May 31, 2013, Elizabeth Hamelin, on behalf of the Centers for 
Disease Control and Prevention, Division of Laboratory Sciences/
National Center for Environmental Health, submitted a request for 
classification of the Quantitation of Organophosphate Metabolites in 
Urine by LC/MS/MS. FDA reviewed the request in order to classify the 
device under the criteria for classification set forth in section 
513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on August 8, 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 862.3652. We have named 
the generic type of device organophosphate test system, and it is 
identified as a device intended to measure organophosphate metabolites 
quantitatively in human urine from individuals who have signs and 
symptoms consistent with cholinesterase poisoning. The data obtained by 
this device is intended to aid in the confirmation and investigation of 
organophosphate exposure.
    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--Organophosphate Test System Risks and Mitigation Measures
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         Identified risks                    Mitigation measures
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False Positive....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
False Negative....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
Public Health Risk from Incorrect   (1) The distribution of these
 Test Results.                       devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
------------------------------------------------------------------------


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    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. This device is subject to premarket 
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has 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.

IV. 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.

List of Subjects in 21 CFR Part 862

    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 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

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


0
2. Add Sec.  862.3652 to subpart D to read as follows:


Sec.  862.3652  Organophosphate test system.

    (a) Identification. An organophosphate test system is a device 
intended to measure organophosphate metabolites quantitatively in human 
urine from individuals who have signs and symptoms consistent with 
cholinesterase poisoning. The data obtained by this device is intended 
to aid in the confirmation and investigation of organophosphate 
exposure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The distribution of these devices is limited to laboratories 
with experienced personnel who are trained to measure and evaluate 
organophosphate exposure and guide public health response.
    (2) Analytical testing must demonstrate the device has appropriate 
performance characteristics, including adequate precision and accuracy 
across the measuring range and near medical decision points.

    Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22590 Filed 10-17-17; 8:45 am]
 BILLING CODE 4164-01-P