81 FR 68293 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range		68293-68295
FR Document		2016-23899

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).

Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Rules and Regulations]
[Pages 68293-68295]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23899]



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Rules and Regulations
                                                Federal Register
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having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

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

[[Page 68293]]



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.

-----------------------------------------------------------------------

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 protected].

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

[[Page 68294]]

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.
---------------------------------------------------------------------------

    \1\ For more information, see Medical Device Reporting (MDR) 
database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
---------------------------------------------------------------------------

    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

[[Page 68295]]

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

68293

Rules and Regulations Federal Register
Vol. 81, No. 192

Tuesday, October 4, 2016

This section of the FEDERAL REGISTER I. Statutory Background devices upon the date of publication of
contains regulatory documents having general the list in the Federal Register. FDA
Under section 513 of the Federal
applicability and legal effect, most of which published that list in the Federal
are keyed to and codified in the Code of Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must Register of January 21, 1998 (63 FR
Federal Regulations, which is published under 3142).
50 titles pursuant to 44 U.S.C. 1510. classify devices into one of three
regulatory classes: Class I, class II, or Section 510(m)(2) of the FD&C Act
The Code of Federal Regulations is sold by class III. FDA classification of a device provides that 1 day after the date of
the Superintendent of Documents. Prices of is determined by the amount of publication of the list under section
new books are listed in the first FEDERAL regulation necessary to provide a 510(m)(1), FDA may exempt a class II
REGISTER issue of each week. reasonable assurance of the safety and device on its own initiative or upon
effectiveness of the device. Under the petition of an interested person if FDA
Medical Device Amendments of 1976 determines that a 510(k) is not necessary
DEPARTMENT OF HEALTH AND (1976 amendments) (Pub. L. 94–295), as to provide a reasonable assurance of the
HUMAN SERVICES amended by the Safe Medical Devices safety and effectiveness of the device.
Act of 1990 (Pub. L. 101–629), devices This section requires FDA to publish in
Food and Drug Administration the Federal Register a notice of intent
are to be classified into class I (general
controls) if there is information showing to exempt a device, or of the petition,
21 CFR Part 862 and to provide a 30-day comment
that the general controls of the FD&C
Act are sufficient to assure safety and period. Within 120 days of publication
[Docket No. FDA–2016–P–1026] effectiveness; into class II (special of this document, FDA must publish in
controls) if general controls, by the Federal Register its final
Medical Devices; Exemption From determination regarding the exemption
themselves, are insufficient to provide
Premarket Notification: Method, of the device that was the subject of the
reasonable assurance of safety and
Metallic Reduction, Glucose (Urinary, notice. If FDA fails to respond to a
effectiveness, but there is sufficient
Nonquantitative) Test System in a petition under this section within 180
information to establish special controls
Reagent Tablet Format days of receiving it, the petition shall be
to provide such assurance; and into
AGENCY: Food and Drug Administration, class III (premarket approval) if there is deemed granted.
HHS. insufficient information to support FDA classified the urinary glucose
classifying a device into class I or class (nonquantitative) test system into class
ACTION: Final order.
II and the device is a life sustaining or II effective July 30, 1987 (52 FR 16102
SUMMARY: The Food and Drug life supporting device, or is for a use at 16122, May 1, 1987). The
Administration (FDA) is publishing an which is of substantial importance in classification for urinary glucose
order denying a petition requesting preventing impairment of human health (nonquantitative) test system is at
exemption from the premarket or presents a potential unreasonable risk § 862.1340 (21 CFR 862.1340). The
notification requirements for ‘‘method, of illness or injury. urinary glucose (nonquantitative) test
metallic reduction, glucose (urinary, Section 510(k) of the FD&C Act (21 system is identified as a device that is
nonquantitative)’’ devices that are in a U.S.C. 360(k)) and the implementing intended to measure glucosuria (glucose
reagent tablet format and are classified regulations (21 CFR part 807) require in urine). Urinary glucose
as class II devices as urinary glucose persons who intend to market a device (nonquantitative) measurements are
(nonquantitative) test system intended for human use to submit a used in the diagnosis and treatment of
(hereinafter referred to as ‘‘copper premarket notification (510(k)) to FDA carbohydrate metabolism disorders
reduction tablet test’’). Urinary glucose containing information that allows FDA including diabetes mellitus,
(nonquantitative) measurements are to determine whether the device is hypoglycemia, and hyperglycemia.
used in the diagnosis and treatment of ‘‘substantially equivalent’’ within the Devices under this classification
carbohydrate metabolism disorders meaning of section 513(i) of the FD&C regulation require premarket
including diabetes mellitus, Act to a legally marketed device that notification under section 510(k) of the
hypoglycemia, and hyperglycemia. FDA does not require premarket approval FD&C Act.
is publishing this order in accordance (PMA).
On November 21, 1997, the President II. Criteria for Exemption
with procedures established by the Food
and Drug Administration Modernization signed into law FDAMA (Pub. L. 105– There are a number of factors FDA
Act of 1997 (FDAMA). 115). Section 206 of FDAMA, in part, may consider to determine whether a
added a new section, 510(m), to the 510(k) is necessary to provide
DATES: This order is effective October 4,
FD&C. Section 510(m)(1) of the FD&C reasonable assurance of the safety and
2016.
Act requires FDA, within 60 days after effectiveness of a class II device. These
asabaliauskas on DSK3SPTVN1PROD with RULES

FOR FURTHER INFORMATION CONTACT: enactment of FDAMA, to publish in the factors are discussed in the guidance the
Sheila Connors, Center for Devices and Federal Register a list of each type of Agency issued on February 19, 1998,
Radiological Health (CDRH), Food and class II device that does not require a entitled ‘‘Procedures for Class II Device
Drug Administration, 10903 New report under section 510(k) to provide Exemptions from Premarket
Hampshire Ave., Bldg. 66, rm. 4620, reasonable assurance of safety and Notification, Guidance for Industry and
Silver Spring, MD 20993–0002, 301– effectiveness. Section 510(m) of the CDRH Staff’’ (Ref. 1). Accordingly, FDA
796–6181, Sheila.Connors@fda.hhs.gov. FD&C Act further provides that a 510(k) generally considers the following factors
SUPPLEMENTARY INFORMATION: will no longer be required for these to determine whether premarket

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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Rules and Regulations 68295

exemption from the premarket February 1998, available at http:// class III. FDA classification of a device
notification requirements applies, in the www.fda.gov/downloads/ is determined by the amount of
case of IVD devices, only to those MedicalDevices/ regulation necessary to provide a
devices under part 862 for which DeviceRegulationandGuidance/ reasonable assurance of the safety and
GuidanceDocuments/UCM080199.pdf.
misdiagnosis, as a result of using the effectiveness of the device. Under the
device, would not be associated with Dated: September 28, 2016. Medical Device Amendments of 1976
high morbidity or mortality. FDA has Leslie Kux, (1976 amendments) (Pub. L. 94–295), as
previously assessed that this limitation Associate Commissioner for Policy. amended by the Safe Medical Devices
is exceeded, and a premarket [FR Doc. 2016–23899 Filed 10–3–16; 8:45 am] Act of 1990 (Pub. L. 101–629), devices
notification is necessary to provide a BILLING CODE 4164–01–P are to be classified into class I (general
reasonable assurance of the safety and controls) if there is information showing
effectiveness of an IVD device, when that the general controls of the FD&C
such device is intended for use in DEPARTMENT OF HEALTH AND Act are sufficient to assure safety and
screening or diagnosis of familial or HUMAN SERVICES effectiveness; into class II (special
acquired genetic disorders, including controls) if general controls, by
inborn errors of metabolism Food and Drug Administration themselves, are insufficient to provide
(§ 862.9(c)(2)) or intended for use in reasonable assurance of safety and
diabetes management (§ 862.9(c)(5)). 21 CFR Part 862 effectiveness, but there is sufficient
The petition argued that the copper information to establish special controls
[Docket No. FDA–2016–P–0159]
reduction tablet test is not intended for to provide such assurance; and into
use in screening or diagnosis of familial Medical Devices; Exemption From class III (premarket approval) if there is
and acquired genetic disorders, Premarket Notification; Method, insufficient information to support
including inborn errors of metabolism, Metallic Reduction, Glucose (Urinary, classifying a device into class I or class
or for use in diabetes management. Nonquantitative) Test System in a II and the device is a life-sustaining or
However, as explained previously, FDA Reagent Tablet Format life-supporting device, or is for a use
disagrees and believes that the copper which is of substantial importance in
reduction tablet test described in the AGENCY: Food and Drug Administration, preventing impairment of human
petition is intended for such uses and HHS. health, or presents a potential
would likely exceed the limitations ACTION: Final order. unreasonable risk of illness or injury.
previously mentioned. Section 510(k) of the FD&C Act (21
Accordingly, for all of the foregoing SUMMARY: The Food and Drug U.S.C. 360(k)) and the implementing
reasons, the petition failed to Administration (FDA) is publishing an regulations (21 CFR part 807) require
demonstrate that a premarket order denying a petition requesting persons who intend to market a device
submission is not necessary to provide exemption from the premarket intended for human use to submit a
a reasonable assurance of the safety and notification requirements for method, premarket notification (510(k)) to FDA
effectiveness of the device intended for metallic reduction, glucose (urinary, containing information that allows FDA
such uses. Therefore, FDA is issuing nonquantitative) devices that are in a to determine whether the device is
this order denying the petition reagent tablet format and are classified ‘‘substantially equivalent’’ within the
requesting exemption for a method, as class II devices as urinary glucose meaning of section 513(i) of the FD&C
metallic reduction, glucose (urinary, (nonquantitative) test system Act to a legally marketed device that
nonquantitative) test system in a reagent (hereinafter referred to as ’’copper does not require premarket approval.
tablet format that is intended to measure reduction tablet test’’). Urinary glucose On November 21, 1997, the President
glucosuria (glucose in urine) from the (nonquantitative) measurements are signed into law FDAMA (Pub. L. 105–
premarket notification requirements. used in the diagnosis and treatment of 115). Section 206 of FDAMA, in part,
Manufacturers of this device type must carbohydrate metabolism disorders added section 510(m) to the FD&C Act.
continue to submit and receive FDA including diabetes mellitus, Section 510(m)(1) of the FD&C Act
clearance of a 510(k) before marketing hypoglycemia, and hyperglycemia. FDA requires FDA, within 60 days after
their device, as well as comply with all is publishing this order in accordance enactment of FDAMA, to publish in the
other applicable requirements under the with procedures established by the Food Federal Register a list of each type of
FD&C Act. and Drug Administration Modernization class II device that does not require a
Act of 1997 (FDAMA). report under section 510(k) of the FD&C
V. Reference Act to provide reasonable assurance of
The following reference is on display DATES: This order is effective October 4,
safety and effectiveness. Section 510(m)
in the Division of Dockets Management 2016. of the FD&C Act further provides that a
(HFA–305), Food and Drug FOR FURTHER INFORMATION CONTACT: 510(k) will no longer be required for
Administration, 5630 Fishers Lane, Rm. Sheila Connors, Center for Devices and these devices upon the date of
1061, Rockville, MD 20852, and is Radiological Health (CDRH), Food and publication of the list in the Federal
available for viewing by interested Drug Administration, 10903 New Register. FDA published that list in the
persons between 9 a.m. and 4 p.m., Hampshire Ave., Bldg. 66, Rm. 4620, Federal Register of January 21, 1998 (63
Monday through Friday; it is also Silver Spring, MD 20993–0002, 301– FR 3142).
available electronically at http:// 796–6181, Sheila.Connors@fda.hhs.gov. Section 510(m)(2) of the FD&C Act
asabaliauskas on DSK3SPTVN1PROD with RULES

www.regulations.gov. FDA has verified SUPPLEMENTARY INFORMATION: provides that 1 day after the date of
the Web site address, as of the date this publication of the list under section
document publishes in the Federal I. Statutory Background 510(m)(1), FDA may exempt a class II
Register, but Web sites are subject to Under section 513 of the Federal device on its own initiative or upon
change over time. Food, Drug, and Cosmetic Act (the petition of an interested person, if FDA
1. ‘‘Procedures for Class II Device FD&C Act) (21 U.S.C. 360c), FDA must determines that a 510(k) is not necessary
Exemptions from Premarket Notification, classify devices into one of three to provide reasonable assurance of the
Guidance for Industry and CDRH Staff,’’ regulatory classes: Class I, class II, or safety and effectiveness of the device.

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Document Created: 2016-10-04 03:04:23
Document Modified: 2016-10-04 03:04:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective October 4, 2016.
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 protected]
FR Citation		81 FR 68293

81 FR 68293 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration