[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61004-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21463]


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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; Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care Use.'' This 
guidance describes studies and information 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.

DATES: The announcement of the guidance is published in the Federal 
Register on September 29, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 61005]]

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-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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
Use'' to the Office of Policy, 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. 3566, Silver Spring, MD 20993-0002, 301-796-6147.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 11, 2016 (81 FR 70122), 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.
    On November 30, 2018, FDA published a notice of availability in the 
Federal Register (83 FR 61648) of a draft guidance that proposed 
revisions to the guidance. FDA proposed modifications based on feedback 
received from stakeholders and to better align with the evolving 
understanding and development of these types of devices.
    FDA considered comments received on the draft guidance and made 
revisions as appropriate in response to the comments, including a minor 
edit encouraging manufacturers to consider design features that will 
aid in user accessibility and a technical edit in hemoglobin testing 
concentration. This revised guidance replaces the existing final 
guidance of the same title issued on October 11, 2016.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents 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.

II. Electronic Access

    Persons interested in obtaining a copy of the 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 
guidance 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 CDRH-Guidance@fda.hhs.gov to receive an electronic copy of 
the document. Please use the document number 1755 and title to identify 
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required 
for this guidance. The collections of information in the following FDA 
guidances and regulations have been approved by OMB as listed in the 
following table:

[[Page 61006]]



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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket Notification.       0910-0120
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff``.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
Recommendations for Clinical     CLIA Waiver                   0910-0598
 Laboratory Improvement           Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices--Guidance
 for Industry and Food and Drug
 Administration Staff.
Administrative Procedures for    Administrative                0910-0607
 CLIA Categorization--Guidance    Procedures for
 for Industry and Food and Drug   Clinical Laboratory
 Administration Staff.            Improvement Amendments
                                  of 1988 Categorization
                                  (42 CFR 493.17).
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    Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21463 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


