Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication, 39929-39930 [2016-14459]

Download as PDF Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices Dated: June 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–14461 Filed 6–17–16; 8:45 am] BILLING CODE 4164–01–P 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. 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, NonQuantitative) 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: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your VerDate Sep<11>2014 17:05 Jun 17, 2016 Jkt 238001 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 https://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, NonQuantitative) 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 https://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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 39929 redacted/blacked out, will be available for public viewing and posted on https:// 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: https://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 https:// 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, anahita.loloeimarsal@ 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 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 E:\FR\FM\20JNN1.SGM 20JNN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES 39930 Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices 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, VerDate Sep<11>2014 17:05 Jun 17, 2016 Jkt 238001 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 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, (https://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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on October 19, 2016, from 8:15 a.m. to 5 p.m. SUMMARY: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: BRUDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss the efficacy and safety of new drug E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39929-39930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14459]


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

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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, anahita.loloeimarsal@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 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 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, 
(https://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
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