[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Care Use; Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Blood Glucose Monitoring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 This draft guidance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 This draft
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 7, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Blood Glucose Monitoring Test Systems for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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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