81 FR 70122 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 196 (October 11, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use in professional healthcare settings. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.

[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70122-70124]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24430]


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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, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Blood Glucose Monitoring 
Test Systems for Prescription Point-of-Care Use.'' This document 
describes studies and criteria that FDA recommends be used when 
submitting premarket notifications (510(k)s) for blood glucose 
monitoring systems (BGMSs) which are for prescription point-of-care use 
in professional healthcare settings. FDA intends for this document to 
serve as a guide for manufacturers in conducting appropriate 
performance studies and preparing 510(k)s for these device types.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

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-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care Use; Guidance for Industry and Food and Drug 
Administration Staff; Availability.'' 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

[[Page 70123]]

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.
    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 copy of the guidance document 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, Bldg. 66, Rm. 4623, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6147.

SUPPLEMENTARY INFORMATION: 

I. Background

    This document describes studies and criteria that FDA recommends be 
used when submitting 510(k)s for BGMSs which are for prescription 
point-of-care use in professional settings. FDA intends for this 
document to serve as a guide for manufacturers in conducting 
appropriate performance studies and preparing 510(k)s for these device 
types. This document is not meant to address self-monitoring blood 
glucose test systems (SMBGs) for over-the-counter (OTC) home use by 
lay-users. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of the guidance ``Self-Monitoring Blood 
Glucose Test Systems for Over-the-Counter Use'' to address those device 
types.
    Historically, FDA has not recommended different types of 
information in 510(k)s for BGMSs used by healthcare professionals as 
compared to SMBGs intended for home use by lay-users. However, it has 
become increasingly clear that these different use settings have 
distinct intended use populations with unique characteristics that can 
impact device design specifications, and that manufacturers should take 
these unique characteristics into account when designing their devices. 
In order to distinguish between FDA recommendations for prescription-
use blood glucose meters, which are intended for use in point-of-care 
professional healthcare settings, and SMBG devices intended for home 
use for self-monitoring by lay-persons, the Agency is issuing two 
separate guidances for (i) BGMSs intended for use in point-of-care 
professional healthcare settings, and (ii) SMBGs intended for home use 
for self-monitoring by lay-users. FDA believes that in making this 
distinction, BGMSs can be better designed to meet the needs of their 
intended use populations, thereby providing greater safety and 
efficacy.
    Because BGMSs are used in professional healthcare settings, they 
are more likely to be used on multiple patients. The Centers for 
Medicare and Medicaid Services and Centers for Disease Control and 
Prevention have expressed concern over the possibility that blood 
glucose meters can transmit bloodborne pathogens if these devices are 
contaminated with blood specimens and shared between users without 
effective cleaning, disinfecting, and appropriate infection control 
measures. This document describes certain design features and capacity 
for cleaning and disinfection to prevent the spread of bloodborne 
pathogens.
    In addition, concerns have been raised citing the inability of 
currently cleared BGMSs to perform effectively in professional 
healthcare settings because these devices have not been adequately 
evaluated in some of the populations in which they are being used. 
Patients in professional healthcare settings are often fundamentally 
different than lay-users using these devices at home. Patients in 
professional healthcare settings can be acutely ill and medically 
fragile and are more likely to present physiological and pathological 
factors that could interfere with glucose measurements relative to lay-
users. Errors in BGMSs accuracy can lead to incorrect insulin dosing, 
which, when combined with other factors, can lead to increased episodes 
of hypoglycemia. For hospitalized patients who may be seriously ill, 
glucose meter inaccuracies could further increase risk to health. This 
document describes studies that can be conducted to demonstrate BGMS 
performance for devices intended to be used in diverse professional 
healthcare settings on subjects in various states of health. While FDA 
recommends that the information described in this guidance be included 
in premarket submissions for BGMSs, submissions containing alternative 
information may be sufficient if able to demonstrate substantial 
equivalence to a legally marketed predicate device.
    In the Federal Register of January 7, 2014 (79 FR 830), the Agency 
issued the draft guidance entitled ``Blood Glucose Monitoring Test 
Systems for Prescription Point-of-Care Use''. In the Federal Register 
of April 9, 2014 (79 FR 19622), the Agency announced that the deadline 
for the comment period would be extended until May 7, 2014, to allow 
for more public comments on this draft guidance document. FDA 
considered the comments received on this draft guidance and FDA revised 
the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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.

III. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Blood Glucose Monitoring 
Test Systems for Prescription Point-of-Care

[[Page 70124]]

Use'' may send an email request to [email protected] to receive 
an electronic copy of the document. Please use the document number 1755 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and guidance. 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 21 CFR part 807 subpart E have 
been approved under OMB control number 0910-0120; the collections of 
information in 21 CFR 801 and 21 CFR 809.10 have been approved under 
OMB control number 0910-0485; the collections of information in 21 CFR 
part 820 have been approved under OMB control number 0910-0073; the 
collections of information in the guidance document ``Recommendations: 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver 
Applications for Manufacturers of In Vitro Diagnostic Devices'' have 
been approved under OMB control number 0910-0598; and the collections 
of information in the guidance document ``Requests for Feedback on 
Medical Device Submissions: The Pre-Submission Program and Meetings 
with Food and Drug Administration Staff'' have been approved under OMB 
control number 0910-0756.

    Dated: October 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24430 Filed 10-7-16; 8:45 am]
 BILLING CODE 4164-01-P