[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70122-70124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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