81 FR 39929 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 118 (June 20, 2016)

Page Range		39929-39930
FR Document		2016-14459

The Food and Drug Administration (FDA) is republishing in its entirety a notice entitled ``Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non- Quantitative) Test System in a Reagent Tablet Format'' that published in the Federal Register on May 4, 2016 (81 FR 26802). FDA is republishing to correct an inadvertent error in the Docket Number and to announce a revised comment period. FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Federal Register, Volume 81 Issue 118 (Monday, June 20, 2016)

[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39929-39930]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; republication.

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

SUMMARY: The Food and Drug Administration (FDA) is republishing in its 
entirety a notice entitled ``Medical Devices; Exemption from Premarket 
Notification: Method, Metallic Reduction, Glucose (Urinary, Non-
Quantitative) Test System in a Reagent Tablet Format'' that published 
in the Federal Register on May 4, 2016 (81 FR 26802). FDA is 
republishing to correct an inadvertent error in the Docket Number and 
to announce a revised comment period. FDA is announcing that it has 
received a petition requesting exemption from the premarket 
notification requirements for a method, metallic reduction, glucose 
(urinary, non-quantitative) test system in a reagent tablet format that 
is intended to measure glucosuria (glucose in urine). Method, metallic 
reduction, glucose (urinary, non-quantitative) test systems in a 
reagent tablet format are used in the diagnosis and treatment of 
carbohydrate metabolism disorders including diabetes mellitus, 
hypoglycemia, and hyperglycemia. FDA is publishing this notice to 
obtain comments in accordance with procedures established by the Food 
and Drug Administration Modernization Act of 1997 (FDAMA).

DATES: Submit either electronic or written comments by July 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-P-1026 for ``Medical Devices; Exemption From Premarket 
Notification: Method, Metallic Reduction, Glucose (Urinary, Non-
Quantitative) Test System in a Reagent Tablet Format.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ana Loloei Marsal, Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4552, Silver Spring, MD 20993-0002, 301-
796-8774, [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 safety and effectiveness. 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

[[Page 39930]]

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.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the FD&C Act through the 
issuance of classification regulations into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as 
postamendments devices), are classified through the premarket 
notification process under section 510(k) of the FD&C Act (21 U.S.C. 
360(k)). Section 510(k) of the FD&C Act and the implementing 
regulations, 21 CFR part 807, require persons who intend to market a 
new device to submit a premarket notification (510(k)) containing 
information that allows FDA to determine whether the new 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 a new 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 date of 
publication of the list under section 510(m)(1), FDA may exempt a 
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. 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.

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).

III. Proposed Class II Device Exemptions

    FDA has received the following petition requesting an exemption 
from premarket notification for a class II device: Martin O'Connor, 
Germaine Laboratories, Inc., 11030 Wye Dr., San Antonio, TX 78217, for 
its Method, Metallic Reduction, Glucose (urinary, non-quantitative) 
classified under 21 CFR 862.1340. FDA previously announced that it 
received this petition in a notice entitled ``Medical Devices; 
Exemption from Premarket Notification: Method, Metallic Reduction, 
Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet 
Format'' that appeared in the Federal Register of May 4, 2016 (81 FR 
26802). The document was published with the incorrect docket number. 
This notice includes the correct docket number for the petition.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) 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, 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf).

    Dated: June 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14459 Filed 6-17-16; 8:45 am]
 BILLING CODE 4164-01-P

39930 Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices

class III (premarket approval) if there is FDA must publish in the Federal DEPARTMENT OF HEALTH AND
insufficient information to support Register its final determination HUMAN SERVICES
classifying a device into class I or class regarding the exemption of the device
II and the device is a life sustaining or that was the subject of the notice. If FDA Food and Drug Administration
life supporting device, or is for a use fails to respond to a petition under this
[Docket No. FDA–2016–N–0001]
which is of substantial importance in section within 180 days of receiving it,
preventing impairment of human health the petition shall be deemed granted. Bone, Reproductive and Urologic
or presents a potential unreasonable risk Drugs Advisory Committee; Notice of
of illness or injury. II. Criteria for Exemption
Meeting
Most generic types of devices that There are a number of factors FDA
were on the market before the date of may consider to determine whether a AGENCY: Food and Drug Administration,
the 1976 amendments (May 28, 1976) 510(k) is necessary to provide HHS.
(generally referred to as preamendments reasonable assurance of the safety and ACTION: Notice.
devices) have been classified by FDA effectiveness of a class II device. These
under the procedures set forth in section factors are discussed in the guidance the SUMMARY: The Food and Drug
513(c) and (d) of the FD&C Act through Agency issued on February 19, 1998, Administration (FDA) announces a
the issuance of classification regulations entitled ‘‘Procedures for Class II Device forthcoming public advisory committee
into one of these three regulatory Exemptions from Premarket meeting of the Bone, Reproductive and
classes. Devices introduced into Notification, Guidance for Industry and Urologic Drugs Advisory Committee.
interstate commerce for the first time on CDRH Staff’’ (Ref. 1). The general function of the committee is
or after May 28, 1976 (generally referred to provide advice and recommendations
to as postamendments devices), are III. Proposed Class II Device to the Agency on FDA’s regulatory
classified through the premarket Exemptions issues. The meeting will be open to the
notification process under section FDA has received the following public.
510(k) of the FD&C Act (21 U.S.C. petition requesting an exemption from DATES: The meeting will be held on
360(k)). Section 510(k) of the FD&C Act premarket notification for a class II October 19, 2016, from 8:15 a.m. to 5
and the implementing regulations, 21 device: Martin O’Connor, Germaine p.m.
CFR part 807, require persons who Laboratories, Inc., 11030 Wye Dr., San
intend to market a new device to submit ADDRESSES: FDA White Oak Campus,
Antonio, TX 78217, for its Method,
a premarket notification (510(k)) 10903 New Hampshire Ave., Bldg. 31
Metallic Reduction, Glucose (urinary,
containing information that allows FDA Conference Center, the Great Room (Rm.
non-quantitative) classified under 21
to determine whether the new device is 1503), Silver Spring, MD 20993–0002.
CFR 862.1340. FDA previously
‘‘substantially equivalent’’ within the Answers to commonly asked questions
announced that it received this petition
meaning of section 513(i) of the FD&C including information regarding special
in a notice entitled ‘‘Medical Devices;
Act to a legally marketed device that accommodations due to a disability,
Exemption from Premarket Notification:
does not require premarket approval. visitor parking, and transportation may
Method, Metallic Reduction, Glucose
On November 21, 1997, the President be accessed at: http://www.fda.gov/
(Urinary, Non-Quantitative) Test System
signed into law FDAMA (Pub. L. 105– AdvisoryCommittees/
in a Reagent Tablet Format’’ that
115). Section 206 of FDAMA, in part, AboutAdvisoryCommittees/
appeared in the Federal Register of May
added a new section, 510(m), to the ucm408555.htm.
4, 2016 (81 FR 26802). The document
FD&C Act. Section 510(m)(1) of the was published with the incorrect docket FOR FURTHER INFORMATION CONTACT:
FD&C Act requires FDA, within 60 days number. This notice includes the correct Kalyani Bhatt, Center for Drug
after enactment of FDAMA, to publish docket number for the petition. Evaluation and Research, Food and
in the Federal Register a list of each Drug Administration, 10903 New
type of class II device that does not IV. Reference Hampshire Ave., Bldg. 31, Rm. 2417,
require a report under section 510(k) of The following reference is on display Silver Spring, MD 20993–0002, 301–
the FD&C Act to provide reasonable in the Division of Dockets Management 796–9001, FAX: 301–847–8533, email:
assurance of safety and effectiveness. (see ADDRESSES) and is available for BRUDAC@fda.hhs.gov, or FDA Advisory
Section 510(m) of the FD&C Act further viewing by interested persons between Committee Information Line, 1–800–
provides that a 510(k) will no longer be 9 a.m. and 4 p.m., Monday through 741–8138 (301–443–0572 in the
required for these devices upon the date Friday; it is also available electronically Washington, DC area). A notice in the
of publication of the list in the Federal at http://www.regulations.gov. FDA has Federal Register about last minute
Register. FDA published that list in the
verified the Web site address, as of the modifications that impact a previously
Federal Register of January 21, 1998 (63
date this document publishes in the announced advisory committee meeting
FR 3142).
Section 510(m)(2) of the FD&C Act Federal Register, but Web sites are cannot always be published quickly
provides that 1 day after date of subject to change over time. enough to provide timely notice.
publication of the list under section 1. ‘‘Procedures for Class II Device Therefore, you should always check the
510(m)(1), FDA may exempt a device on Exemptions from Premarket Notification, Agency’s Web site at http://
its own initiative or upon petition of an Guidance for Industry and CDRH Staff,’’ www.fda.gov/AdvisoryCommittees/
interested person if FDA determines February 1998, (http://www.fda.gov/ default.htm and scroll down to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

downloads/MedicalDevices/ appropriate advisory committee meeting
that a 510(k) is not necessary to provide DeviceRegulationandGuidance/
reasonable assurance of the safety and link, or call the advisory committee
GuidanceDocuments/UCM080199.pdf). information line to learn about possible
effectiveness of the device. This section
requires FDA to publish in the Federal Dated: June 14, 2016. modifications before coming to the
Register a notice of intent to exempt a Leslie Kux, meeting.
device, or of the petition, and to provide Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION:
a 30-day comment period. Within 120 [FR Doc. 2016–14459 Filed 6–17–16; 8:45 am] Agenda: The committee will discuss
days of publication of this document, BILLING CODE 4164–01–P the efficacy and safety of new drug

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Document Created: 2016-06-18 00:09:10
Document Modified: 2016-06-18 00:09:10

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		Notices
Action		Notice; republication.
Dates		Submit either electronic or written comments by July 20, 2016.
Contact		Ana Loloei Marsal, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4552, Silver Spring, MD 20993-0002, 301- 796-8774, [email protected]
FR Citation		81 FR 39929

81 FR 39929 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 118 (June 20, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration