[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70120-70122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24431]
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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; 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 ``Self-Monitoring Blood
Glucose Test Systems for Over-the-Counter Use.'' This document
describes studies and criteria that FDA recommends be used when
submitting premarket notifications (510(k)s) for self-monitoring blood
glucose test systems (SMBGs) intended for over-the-counter (OTC) home
use by lay-users.
[[Page 70121]]
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-1446 for ``Self-Monitoring Blood Glucose Test Systems for
Over-the-Counter 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
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 single copies of the guidance 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
This document describes studies and criteria that FDA recommends be
used when submitting 510(k)s for SMBGs which are for OTC home use by
lay users. 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 blood glucose monitoring test systems (BGMSs) which are
intended for prescription point-of-care use in professional healthcare
settings (e.g., hospitals, physician offices, long term care
facilities, etc.). Elsewhere in this issue of the Federal Register, FDA
is announcing the availability of the guidance ``Blood Glucose
Monitoring Test Systems for Prescription Point-of-Care 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 BGMSs, which are intended for use in point-of-care professional
healthcare settings, and SMBGs intended for use for self-monitoring by
lay users, the Agency is issuing two separate guidances for: (1)
Prescription use blood glucose meters, for use in point-of-care
professional healthcare settings and (2) OTC SMBG devices intended for
home use for self-monitoring by lay persons. FDA believes that in
making this distinction, SMBGs can be better designed to meet the needs
of their intended use populations, thereby providing greater safety and
efficacy. While FDA recommends that the information described in this
guidance be included in premarket submissions for SMBGs, submissions
containing alternative information may be sufficient if able to
demonstrate
[[Page 70122]]
substantial equivalence to a legally marketed predicate device.
In the Federal Register of January 7, 2014 (79 FR 829), the Agency
issued the draft guidance entitled ``Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter 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 ``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.
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 ``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 1756 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; 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. 2016-24431 Filed 10-7-16; 8:45 am]
BILLING CODE 4164-01-P