[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 830-831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00023]


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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Care Use; Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Blood Glucose Monitoring 
Test Systems for Prescription Point-of-Care Use.'' This draft guidance 
document describes studies and criteria FDA recommends for blood 
glucose monitoring test systems (BGMSs) which are for prescription 
point-of-care use. 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 This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 7, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 blood glucose monitoring test systems (BGMSs) which are 
for prescription point-of-care use. 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 test systems (glucose 
meters) that measure blood glucose concentrations are widely used in 
hospitals as well as in a variety of other clinical settings including 
both acute and chronic care facilities, general hospital wards and 
intensive care units, physicians' offices, assisted living facilities 
and nursing homes.
    Historically, FDA has not recommended different types of 
information in premarket submissions (510(k)s) for blood glucose meters 
used by medical professionals as compared to over-the-counter self-
monitoring devices intended for use by lay users. In recent years, 
however, concerns have been raised including infection control issues 
related to point-of-care glucose meters. According to the Centers for 
Medicare and Medicaid Services (CMS) and the Centers for Disease 
Control and Prevention (CDC), blood glucose monitoring devices can 
transmit bloodborne pathogens if these devices are contaminated with 
blood specimens and are shared between users without effective 
cleaning, disinfecting and appropriate infection control measures. 
Because BGMS devices, which are used in professional healthcare 
settings, are more likely to be used on multiple patients, this type of 
use requires certain design features and cleaning capability to prevent 
the spread of blood-borne pathogens.
    In addition, concerns have been raised citing the inability of 
currently cleared BGMS devices to perform effectively in professional 
healthcare settings because the device's safety and effectiveness have 
not been evaluated for some of the intended use populations. Patients 
in these 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

[[Page 831]]

that could interfere with glucose measurements as compared to the lay 
population. Errors in BGMS device 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, any inaccuracies in the meters would further increase 
the risk to these patients. Previously, most blood glucose monitoring 
devices, even those intended to be used by healthcare professionals, 
were submitted to FDA with claims for OTC use. Thus, they were 
evaluated for use in the lay population, and the specific issues that 
occur in the professional healthcare setting were never addressed, the 
performance of the devices was not evaluated in the intended use 
population, and the scientific and clinical issues may not have been 
adequately addressed for these uses. Therefore, where devices are 
intended for use in professional healthcare settings, distinct 
performance parameters are proposed as recommendations in the draft 
guidance.

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 Blood 
Glucose Monitoring Test Systems for Prescription Point-of-Care 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 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 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
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 
1755 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. 2014-00023 Filed 1-6-14; 8:45 am]
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