[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Rules and Regulations]
[Pages 68293-68295]
[FR Doc No: 2016-23899]

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Rules and Regulations
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2016-P-1026]

Medical Devices; Exemption From Premarket Notification: Method,
Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a
Reagent Tablet Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
denying a petition requesting exemption from the premarket notification
requirements for ``method, metallic reduction, glucose (urinary,
nonquantitative)'' devices that are in a reagent tablet format and are
classified as class II devices as urinary glucose (nonquantitative)
test system (hereinafter referred to as ``copper reduction tablet
test''). Urinary glucose (nonquantitative) measurements are used in the
diagnosis and treatment of carbohydrate metabolism disorders including
diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing
this order in accordance with procedures established by the Food and
Drug Administration Modernization Act of 1997 (FDAMA).

DATES: This order is effective October 4, 2016.

FOR FURTHER INFORMATION CONTACT: Sheila Connors, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4620, Silver Spring, MD 20993-0002, 301-
796-6181<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of the safety and effectiveness of the
device. Under the Medical Device Amendments of 1976 (1976 amendments)
(Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990
(Pub. L. 101-629), devices are to be classified into class I (general
controls) if there is information showing that the general controls of
the FD&C Act are sufficient to assure safety and effectiveness; into
class II (special controls) 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 such assurance; and into class III (premarket
approval) if there is insufficient information to support classifying a
device into class I or class II and the device is a life sustaining or
life supporting device, or is for a use which is of substantial
importance in preventing impairment of human health or presents a
potential unreasonable risk of illness or injury.
    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the
implementing regulations (21 CFR part 807) require persons who intend
to market a device intended for human use to submit a premarket
notification (510(k)) to FDA containing information that allows FDA to
determine whether the device is ``substantially equivalent'' within the
meaning of section 513(i) of the FD&C Act to a legally marketed device
that does not require premarket approval (PMA).
    On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of FDAMA, in part, added a new section, 510(m),
to the FD&C. Section 510(m)(1) of the FD&C Act requires FDA, within 60
days after enactment of FDAMA, to publish in the Federal Register a
list of each type of class II device that does not require a report
under section 510(k) to provide reasonable assurance of safety and
effectiveness. Section 510(m) of the FD&C Act further provides that a
510(k) will no longer be required for these devices upon the date of
publication of the list in the Federal Register. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that 1 day after the
date of publication of the list under section 510(m)(1), FDA may exempt
a class II device on its own initiative or upon petition of an
interested person if FDA determines that a 510(k) is not necessary to
provide a reasonable assurance of the safety and effectiveness of the
device. This section requires FDA to publish in the Federal Register a
notice of intent to exempt a device, or of the petition, and to provide
a 30-day comment period. Within 120 days of publication of this
document, FDA must publish in the Federal Register its final
determination regarding the exemption of the device that was the
subject of the notice. If FDA fails to respond to a petition under this
section within 180 days of receiving it, the petition shall be deemed
granted.
    FDA classified the urinary glucose (nonquantitative) test system
into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1,
1987). The classification for urinary glucose (nonquantitative) test
system is at Sec.  862.1340 (21 CFR 862.1340). The urinary glucose
(nonquantitative) test system is identified as a device that is
intended to measure glucosuria (glucose in urine). Urinary glucose
(nonquantitative) measurements are used in the diagnosis and treatment
of carbohydrate metabolism disorders including diabetes mellitus,
hypoglycemia, and hyperglycemia. Devices under this classification
regulation require premarket notification under section 510(k) of the
FD&C Act.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (Ref. 1). Accordingly, FDA generally
considers the following factors to determine whether premarket

notification is necessary: (1) The device does not have a significant
history of false or misleading claims or risks associated with inherent
characteristics of the device; (2) characteristics of the device
necessary for its safe and effective performance are well established;
(3) changes in the device that could affect safety and effectiveness
will either (a) be readily detectable by users by visual examination or
other means such as routine testing, before causing harm, or (b) not
materially increase the risk of injury, incorrect diagnosis, or
ineffective treatment; and (4) any changes to the device would not be
likely to result in a change in the device's classification. FDA may
also consider that, even when exempting devices, these devices would
still be subject to the limitations on exemptions.

III. Petition

    On March 18, 2016, FDA received a petition requesting an exemption
from premarket notification requirements for copper reduction tablet
tests that are classified as class II devices under Sec.  862.1340,
urinary glucose (nonquantitative) test system, from Martin O'Connor,
Germaine Laboratories, Inc. (See Docket No. FDA-2016-P-1026).
    On May 4, 2016 (81 FR 26802), FDA published a notice in the Federal
Register announcing that this petition had been received in accordance
with section 510(m)(2) of the FD&C Act. On June 20, 2016 (81 FR 39929),
FDA republished a notice of the petition due to an inadvertent error in
the docket number and provided an opportunity for interested persons to
submit comments on the petition by July 20, 2016. FDA received no
comments regarding this petition.
    FDA has completed review of the referenced petition and assessed
the need for 510(k) clearance for copper reduction tablet test against
the criteria laid out in section II. For the reasons described in this
document, FDA has determined that premarket notification is necessary
to provide a reasonable assurance of the safety and effectiveness of
the copper reduction tablet tests classified under Sec.  862.1340 and
assigned the classification product code JIM. Accordingly, FDA
responded to the petition by letter dated September 6, 2016, denying
the petition within the 180-day timeframe under section 510(m)(2) of
the FD&C Act. (See Docket No. FDA-2016-P-1026).

IV. Order

    After reviewing the petition, FDA has determined that the petition
failed to provide information to demonstrate that premarket
notification is not necessary to provide a reasonable assurance of the
safety and effectiveness of the device. Accordingly, FDA is denying the
referenced petition for exemption from the premarket notification
requirements.
    With regard to the first factor (see section II, Criteria for
Exemption), although there have been no medical device reports reported
to the Agency in recent years, there have been numerous reports to the
Agency \1\ and in medical literature of risks associated with the
inherent characteristics of this device, including possible device-
associated deaths, serious injuries, and malfunctions such as burns,
explosions of the product bottle due to heat, and consumption of the
device. For instance, there have been reports in the medical literature
of patients consuming the tablets because of their similarity to pills,
which has led to poisoning and one report of a death. Therefore, FDA
does not agree with the petitioner that the device does not have a
significant history of risks associated with inherent characteristics
of the device.
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    \1\ For more information, see Medical Device Reporting (MDR)
database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
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    Additionally, failure to observe the reaction at all times after
the tablet has been added to the sample is another risk associated with
the inherent characteristics of the device. This can lead to a false-
negative result and result in improper patient management, which can
lead to serious injury or possibly death. The petition does not address
how the device's inherent risks can be mitigated or controlled without
premarket notification to provide a reasonable assurance of the safety
and effectiveness of the device.
    With regard to the second factor, the petition stated that
healthcare and laboratory professionals understand the appropriate use
of a copper reduction tablet test and that a definitive diagnostic or
therapeutic decision should not be based on the result of this method.
However, a copper reduction tablet test can be used to evaluate
pediatric patients for possible hereditary metabolic disorders through
detection of reducing substances. For example, although all States
require mandatory newborn screening for genetic metabolic defects,
clinical laboratories may still use this device as a screening test on
pediatric urine samples if there are any suspicions of metabolic
disease prior to receiving newborn screening results or if the newborn
screening results do not match the clinical state of the newborn.
Although further diagnostic testing may be performed to confirm the
result(s), physicians may immediately treat the newborn relying solely
on the result of this test while awaiting the results for any followup
diagnostic tests. False negative results also present a safety and
effectiveness concern because followup diagnostic testing may not be
performed, leading to the failure to start needed treatment for the
newborn. The petition failed to demonstrate that a premarket submission
is not necessary to provide a reasonable assurance of the safety and
effectiveness of the device for such uses, and FDA does not agree that
the characteristics of the device necessary for its safe and effective
use are well established.
    With regard to the third factor, FDA also does not agree that
changes in the device that could affect safety and effectiveness will
either be readily detectable or not materially increase risks. The
petition claimed that users could employ positive or negative controls
to validate the reagents performance. However, while available quality
control materials may contain glucose, they do not contain other
reducing sugars (e.g., galactose, lactose). Therefore, such materials
might not readily detect an issue with the device's safety or
effectiveness in detecting other reducing sugars before causing harm.
The petition argued that well-established protocols and methods could
ensure there is no material increase in risk. The petition provided
insufficient information to support this argument that changes in the
device that could affect safety and effectiveness will either be
readily detectable or not materially increase risks. Moreover, changes
in the device that could affect safety and effectiveness might
materially increase the risk of injury, incorrect diagnosis or
ineffective treatment given the device type's intended uses. The
petition also did not provide information to the contrary. The petition
did not provide any relevant information regarding the fourth factor.
    In addition to these four factors, FDA considers the ``limitations
on exemption.'' Manufacturers of any commercially distributed device
for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to
FDA prior to marketing the device when any of the limitations of
exemption are exceeded. The general limitations of exemption from
premarket notification contained in Sec.  862.9 (21 CFR 862.9) are
broadly applicable to in vitro diagnostic (IVD) devices classified
under part 862 (21 CFR part 862). Under Sec.  862.9, the

exemption from the premarket notification requirements applies, in the
case of IVD devices, only to those devices under part 862 for which
misdiagnosis, as a result of using the device, would not be associated
with high morbidity or mortality. FDA has previously assessed that this
limitation is exceeded, and a premarket notification is necessary to
provide a reasonable assurance of the safety and effectiveness of an
IVD device, when such device is intended for use in screening or
diagnosis of familial or acquired genetic disorders, including inborn
errors of metabolism (Sec.  862.9(c)(2)) or intended for use in
diabetes management (Sec.  862.9(c)(5)). The petition argued that the
copper reduction tablet test is not intended for use in screening or
diagnosis of familial and acquired genetic disorders, including inborn
errors of metabolism, or for use in diabetes management. However, as
explained previously, FDA disagrees and believes that the copper
reduction tablet test described in the petition is intended for such
uses and would likely exceed the limitations previously mentioned.
    Accordingly, for all of the foregoing reasons, the petition failed
to demonstrate that a premarket submission is not necessary to provide
a reasonable assurance of the safety and effectiveness of the device
intended for such uses. Therefore, FDA is issuing this order denying
the petition requesting exemption for a method, metallic reduction,
glucose (urinary, nonquantitative) test system in a reagent tablet
format that is intended to measure glucosuria (glucose in urine) from
the premarket notification requirements. Manufacturers of this device
type must continue to submit and receive FDA clearance of a 510(k)
before marketing their device, as well as comply with all other
applicable requirements under the FD&C Act.

V. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff,'' February 1998,
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23899 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Pages 27424-27425]
[FR Doc No: 2020-09841]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4535-DR; Docket ID FEMA-2020-0001]

Wyoming; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Wyoming (FEMA-4535-DR), dated April 11, 2020,
and related determinations.

DATES: The declaration was issued April 11, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 11, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Wyoming resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Wyoming.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.

    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Lee K. dePalo, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Wyoming have been designated as
adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Wyoming.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-09841 Filed 5-7-20; 8:45 am]
 BILLING CODE 9111-23-P