Document ID: FDA-2013-D-1445-0065
Agency: fda
Document Type: Notice
Title: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care
Use; Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
Posted Date: 2018-11-30T05:00Z

[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61648-61650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]

Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance for industry and FDA staff 
entitled ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care Use.'' This draft guidance document describes studies and 
criteria that FDA recommends be used when submitting premarket 
notifications (510(k)s) for blood glucose monitoring systems (BGMSs) 
that are for prescription point-of-care use. This draft guidance is not 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DATES: Submit either electronic or written comments on the draft 
guidance by February 28, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 61649]]

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-1445 for ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care 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 ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care 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, 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
Use.'' That guidance document described studies and information that 
FDA recommends be used when submitting 510(k)s for BGMSs that are for 
prescription point-of-care use. FDA is now proposing to make 
modifications to the 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.

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 ``Blood 
Glucose Monitoring Test Systems for Prescription Point-of-Care 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 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 ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care Use'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number GUD 1755 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 guidances 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.
Recommendations for Clinical        CLIA Waiver                0910-0598
 Laboratory Improvement Amendments   Applications.
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices--
 Guidance for Industry and Food
 and Drug Administration Staff.

[[Page 61650]]

 
Administrative Procedures for CLIA  Administrative             0910-0607
 Categorization--Guidance for        Procedures for
 Industry and Food and Drug          Clinical Laboratory
 Administration Staff.               Improvement
                                     Amendments of 1988
                                     Categorization (42
                                     CFR 493.17).
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    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26034 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P