[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 829-830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00022]
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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Use; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Self-Monitoring Blood
Glucose Test Systems for Over-the-Counter Use''. This draft guidance
document describes studies and criteria FDA recommends in premarket
submissions for self-monitoring blood glucose test systems (SMBGs)
which are for over-the-counter (OTC) use by lay-persons. When
finalized, FDA intends for this document to guide manufacturers in
conducting appropriate performance studies and preparing premarket
notifications for these device types. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 7, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Self-Monitoring Blood Glucose Test Systems
for Over-the-Counter Use''to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5654, Silver Spring, MD 20993-0002, 301-
796-6136.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document describes studies and criteria FDA
recommends for self-monitoring blood glucose test systems (SMBGs) which
are for over-the-counter (OTC) use by lay-persons. When finalized, FDA
intends for this document to guide manufacturers in conducting
appropriate performance studies and preparing premarket notifications
for these device types. Portable blood glucose monitoring systems (also
called glucose meters) that measure blood glucose concentrations are
used by millions of people with diabetes every day. These devices are
used by patients in a variety of settings including in their homes, at
work, and in schools.
Historically, FDA has not recommended different types of
information in premarket submissions (510(k)s) for blood glucose
monitoring systems used by medical professionals as compared to OTC
devices intended for use by lay users. However, it has become
increasingly clear that these different use settings create distinct
intended use populations with unique characteristics and device design
requirements. 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 those intended for
OTC self-monitoring by lay-persons, the Agency is issuing two separate
draft guidances for (i) prescription use blood glucose meters, for use
in point-of-care professional healthcare settings, and (ii) SMBG
devices intended for OTC self-monitoring by lay-persons. FDA believes
that in making this distinction, SMBG devices can be better designed to
meet the needs of their intended use populations, thereby ensuring
greater safety and efficacy.
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 Agency's current thinking on Self-
Monitoring Blood Glucose Test Systems for Over-the-Counter Use. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all
[[Page 830]]
CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov.
To receive ``Self-Monitoring Blood Glucose Test Systems for Over-
the-Counter Use,'' you may either send an email request to
[email protected] to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1756 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. 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.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: January 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00022 Filed 1-6-14; 8:45 am]
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