[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61640-61642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26028]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1446]


Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 
Use; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance for industry and FDA staff 
entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-
Counter Use.'' This draft guidance document describes studies and 
information that FDA recommends be used when submitting premarket 
notifications (510(k)s) for self-monitoring blood glucose test

[[Page 61641]]

systems (SMBGs) that are for over-the-counter (OTC) home use by lay 
users. This guidance is not meant to address blood glucose monitoring 
test systems (BGMS) that are intended for prescription point-of-care 
use in professional healthcare settings (e.g., hospitals, physician 
offices, and long-term care facilities). This draft guidance is not 
final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 28, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2013-D-1446 for ``Self-Monitoring Blood Glucose Test Systems for 
Over-the-Counter Use.'' 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 Dockets 
Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the draft guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the draft guidance. Submit 
written requests for a single hard copy of the draft guidance document 
entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-
Counter Use'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Leslie Landree, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147.

SUPPLEMENTARY INFORMATION: 

I. Background

    On October 11, 2016, FDA published a final guidance entitled 
``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 
Use.'' This guidance document described studies and information that 
FDA recommends be used when submitting 510(k)s for SMBGs that are for 
OTC home use by lay users. FDA is now proposing to make modifications 
to the final guidance based on feedback received from stakeholders, 
which the Agency believes will better align with the evolving 
understanding and development of these types of devices. When 
finalized, this draft guidance will replace the final guidance of the 
same title issued on October 11, 2016.
    This draft guidance is not meant to address BGMS that are intended 
for prescription point-of-care use in professional healthcare settings 
(e.g., hospitals, physician offices, and long term-care facilities). 
FDA addresses those device types in another guidance entitled, ``Blood 
Glucose Monitoring Test Systems for Prescription Point-of-Care Use.''

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Self-
Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological

[[Page 61642]]

Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of 
``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' 
may send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number GUD 
1756 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the following FDA guidance and regulations have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               no.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
------------------------------------------------------------------------


    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26028 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P


