Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format, 68295-68297 [2016-23901]
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations
asabaliauskas on DSK3SPTVN1PROD with RULES
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
(§ 862.9(c)(2)) or intended for use in
diabetes management (§ 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 https://
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,’’
VerDate Sep<11>2014
17:56 Oct 03, 2016
Jkt 241001
February 1998, available at https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA–2016–P–0159]
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.
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, Sheila.Connors@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
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68295
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.
On November 21, 1997, the President
signed into law FDAMA (Pub. L. 105–
115). Section 206 of FDAMA, in part,
added section 510(m) to the FD&C Act.
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) of the FD&C
Act 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 reasonable assurance of the
safety and effectiveness of the device.
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68296
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations
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
§ 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.
asabaliauskas on DSK3SPTVN1PROD with RULES
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
VerDate Sep<11>2014
17:56 Oct 03, 2016
Jkt 241001
subject to the limitations on
exemptions.
III. Petition
On January 7, 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
§ 862.1340, urinary glucose
(nonquantitative) test system, from
Evelyn Mirza, Biorex Labs, LLC. (See
Docket No. FDA–2016–P–0159).
On March 24, 2016 (81 FR 15728),
FDA published a notice in the Federal
Register announcing that this petition
had been received and provided an
opportunity for interested persons to
submit comments on the petition by
April 25, 2016, in accordance with
section 510(m)(2) of the FD&C Act. FDA
received no comments regarding this
petition.
FDA has completed review of the
previously 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 section IV, 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 § 862.1340
and assigned the classification product
code JIM. Accordingly, FDA responded
to the petition by letter dated July 1,
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–0159.)
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 reasonable assurance of the
safety and effectiveness of the device.
Accordingly, FDA is denying the
previously referenced petition for
exemption from the premarket
notification requirements.
With regard to the first factor (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
1 For more information, see Medical Device
Reporting (MDR) database at https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfMAUDE/search.CFM.
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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 use of the device is
well established without any reports of
patient or user injury, or that the device
does not have a significant history of
risks associated with inherent
characteristics of the device.
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 failed to
demonstrate 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 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 also stated that this device is
used in the diagnosis, monitoring, and
treatment of metabolic disorders such as
diabetes mellitus. However, 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
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04OCR1
asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations
risks. For example, available quality
control materials may contain glucose
but 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 provided insufficient
information to support the position 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 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 § 862.9 (21 CFR 862.9) are broadly
applicable to in vitro diagnostic (IVD)
devices classified under part 862 (21
CFR part 862). Under § 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
(§ 862.9(c)(2)) or intended for use in
diabetes management (§ 862.9(c)(5)).
The copper reduction tablet test
described in the petition is intended for
such uses and would likely exceed the
limitations just described.
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
VerDate Sep<11>2014
17:56 Oct 03, 2016
Jkt 241001
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 https://
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 https://
www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf.
Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23901 Filed 10–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 570
[Docket No. FR–5767–N–05]
RIN 2506–AC35
Section 108 Loan Guarantee Program:
Announcement of Fee To Cover Credit
Subsidy Costs
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Announcement of fee.
AGENCY:
This document announces the
fee that HUD will collect from
borrowers of loans guaranteed under
HUD’s Section 108 Loan Guarantee
Program (Section 108 Program) to offset
the credit subsidy costs of the
guaranteed loans pursuant to
commitments awarded in FY 2017.
SUMMARY:
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DATES:
68297
Effective Date: November 3,
2016.
Paul
Webster, Director, Financial
Management Division, Office of Block
Grant Assistance, Office of Community
Planning and Development, Department
of Housing and Urban Development,
451 7th Street, SW., Room 7180,
Washington, DC 20410; telephone
number 202–402–4563 (this is not a tollfree number). Individuals with speech
or hearing impairments may access this
number through TTY by calling the tollfree Federal Relay Service at 800–877–
8339. FAX inquiries (but not comments)
may be sent to Mr. Webster at 202–708–
1798 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
The Consolidated and Further
Continuing Appropriations Act, 2015
(Public Law 113–235, approved
December 16, 2014) (2015
Appropriations Act) provided that ‘‘the
Secretary shall collect fees from
borrowers . . . to result in a credit
subsidy cost of zero for guaranteeing’’
Section 108 loans. The Continuing
Appropriations Act, 2016 (Public Law
114–53, approved September 30, 2015)
continued the 2015 provision. This
continued funding act was followed by
The Consolidated Appropriations Act,
2016, Public Law 114–133, approved
December 18, 2015) (2016
Appropriations Act), which had
identical language regarding Section 108
credit subsidy to the 2015
Appropriations Act. The fiscal year
2017 HUD appropriations bills under
consideration in the House of
Representatives (H.R. 5394), and the
Senate (S. 2844) also have identical
language regarding the credit subsidy
for the Section 108 Program, and it is
expected that, when enacted, the final
fiscal year 2017 appropriations act will
as well.
On November 3, 2015, HUD
published a final rule (80 FR 67626)
following a February 5, 2015 proposed
rule (80 FR 6470) that amended the
Section 108 Program regulations at 24
CFR part 570 to establish additional
procedures, including procedures for
determining the amount of the fee and
for a 30-day public comment process
when HUD adopts changes to the
assumptions underlying the fee
calculation or if the fee structure itself
raises new considerations for borrowers.
HUD is required to collect fees from
Section 108 borrowers when necessary
to offset the credit subsidy costs to the
Federal government to guarantee
Section 108 loans. Following
E:\FR\FM\04OCR1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Rules and Regulations]
[Pages 68295-68297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2016-P-0159]
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.
-----------------------------------------------------------------------
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, Sheila.Connors@fda.hhs.gov.
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.
On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of FDAMA, in part, added section 510(m) to the
FD&C Act. 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) of the FD&C Act 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 reasonable assurance of the safety and effectiveness of the
device.
[[Page 68296]]
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 January 7, 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 Evelyn Mirza,
Biorex Labs, LLC. (See Docket No. FDA-2016-P-0159).
On March 24, 2016 (81 FR 15728), FDA published a notice in the
Federal Register announcing that this petition had been received and
provided an opportunity for interested persons to submit comments on
the petition by April 25, 2016, in accordance with section 510(m)(2) of
the FD&C Act. FDA received no comments regarding this petition.
FDA has completed review of the previously 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 section IV, 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 July 1,
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-0159.)
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 reasonable assurance of the
safety and effectiveness of the device. Accordingly, FDA is denying the
previously referenced petition for exemption from the premarket
notification requirements.
With regard to the first factor (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 use of the device is well
established without any reports of patient or user injury, or 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 https://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 failed to
demonstrate 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 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
also stated that this device is used in the diagnosis, monitoring, and
treatment of metabolic disorders such as diabetes mellitus. However,
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
[[Page 68297]]
risks. For example, available quality control materials may contain
glucose but 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 provided insufficient
information to support the position 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
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 copper reduction tablet
test described in the petition is intended for such uses and would
likely exceed the limitations just described.
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 https://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 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23901 Filed 10-3-16; 8:45 am]
BILLING CODE 4164-01-P
