
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34356-34357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Clinical Chemistry and Clinical Toxicology Devices Panel of the 
Medical Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Clinical Chemistry and 
Clinical Toxicology Devices Panel of the Medical Devices Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. The 
meeting will be open to the public.

DATES: The meeting will be held on July 21 and July 22, 2016, from 8 
a.m. to 6 p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and 
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 
1116, 10903 New Hampshire Ave., Silver Spring, MD 20993; 
patricio.garcia@fda.hhs.gov; 301-796-6875, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On July 21, 2016, the committee will discuss, make 
recommendations, and vote on information regarding a premarket approval 
application (PMA) panel-track supplement for a proposed change in 
intended use of Dexcom, Inc.'s, Dexcom G5[supreg] Mobile Continuous 
Glucose Monitoring System (CGM) device so that, in addition to tracking 
and trending interstitial fluid glucose concentrations, patients can 
use the device as a replacement for their blood glucose meters and make 
treatment decisions based on the interstitial fluid glucose 
concentration reported by the CGM.
    On July 22, 2016, the committee will discuss and make 
recommendations on information regarding a premarket notification 
(510(k)) submission for the Alere AfinionTM HbA1c Dx point-
of-care test system, sponsored by Alere Technologies AS. The proposed 
intended use, as stated by the sponsor:

    Alere Afinion HbA1c Dx is an in vitro diagnostic test for 
quantitative determination of glycated hemoglobin (% hemoglobin A1c, 
HbA1c) in human whole blood. This test is to be used as an aid in 
the diagnosis of diabetes and as an aid in identifying patients who 
may be at risk for developing diabetes. The measurement of % HbA1c 
is recommended as a marker of long-term metabolic control in persons 
with diabetes mellitus. For use in clinical laboratories and point 
of care laboratory settings.

    Current clinical guidelines contraindicate the use of point-of-care 
hemoglobin A1c (HbA1c) tests to diagnose diabetes. FDA is seeking 
feedback from the clinical community to determine significant, 
scientific and practical, reservations or support for using this point-
of-care HbA1c test as an aid in the diagnosis of diabetes and pre-
diabetes.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before July 
15, 2016. Oral presentations from the public will be scheduled on July 
21 and 22, 2016, between approximately 1 p.m. and 2 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before July 
7, 2016. Time allotted for each presentation may be limited. If the

[[Page 34357]]

number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by July 8, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams, at Annmarie.Williams@fda.hhs.gov, or 301-
796-5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12641 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P


