
[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 829-830]
From the Federal Register Online via the Government Printing 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Use; Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Self-Monitoring Blood 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 This draft guidance 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 This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 7, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Self-Monitoring Blood Glucose Test Systems 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 
dsmica@fda.hhs.gov 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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