83 FR 8885 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 41 (March 1, 2018)

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.

[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8885-8886]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0627]


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 March 29 and 30, 2018, 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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, 
[email protected]; 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 website at https://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 March 29, 2018, the committee will discuss, make 
recommendations, and vote on information regarding a premarket approval 
application to market a novel continuous glucose monitoring (CGM) 
device system, the Senseonics, Inc. Eversense CGM System. This device 
requires minor surgery to implant and remove, and if approved, would 
provide 90 days of sensor glucose values from each implanted sensor.
    The Eversense CGM System measures patients' glucose concentrations 
from subcutaneous interstitial fluid similar to approved CGM systems. 
All CGM devices currently or previously marketed used electrochemistry 
to measure glucose in interstitial fluids, last for 3 to 11 days and 
are inserted via a small-gauge needle by the end user. The proposed CGM 
system uses a fluorescence-based measurement technique, requires minor 
surgery for subcutaneous implantation, and will have a 90-day sensor 
wear period. The proposed CGM sensor also includes a drug component 
(dexamethasone acetate) intended to mitigate negative effects on sensor 
accuracy and sensor life from the foreign body response at the sensor 
insertion site. The proposed intended use, as stated by the sponsor, is 
as follows:
    The Eversense CGM System continually measures glucose levels in 
adults (age 18 and older) with diabetes for the operating life of the 
sensor.
    The system is intended to:
     Aid in the management of diabetes.
     Provide real-time glucose readings.
     Provide glucose trend information.
     Provide alerts for the detection and prediction of 
episodes of low blood glucose (hypoglycemia) and high blood glucose 
(hyperglycemia).
    The system is a prescription device. Historical data from the 
system can be interpreted to aid in providing therapy adjustments. 
These adjustments should be based on patterns seen over time.
    On March 30, 2018, the committee will discuss and make 
recommendations regarding measuring blood glucose using capillary blood 
with blood glucose meters in all hospital patients, including those 
receiving intensive medical intervention/therapy and patients with 
decreased peripheral blood flow, such as with severe hypotension, 
shock, hyperosmolar-hyperglycemia and severe dehydration (e.g., 
patients in intensive care settings). Currently, FDA has cleared one 
glucose meter for use all over the hospital using venous and arterial 
blood. FDA understands that being able to make capillary blood 
measurements in all hospitalized patients using FDA cleared and 
Clinical Laboratory Improvement Amendments (CLIA) waived (i.e., 
designated as waived per the standards in the CLIA) glucose meters 
would be more convenient and timely for hospital staff. FDA would like 
to present new data from capillary blood measurements on glucose meters 
in patients receiving intensive medical intervention/therapy to the 
Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would 
like to receive feedback from the advisory panel on the benefits and 
risks of measuring capillary blood using blood glucose meters in this 
intended use population, and the considerations for CLIA waiver for 
this use.
    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 website 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 website after the meeting. Background material is 
available at https://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 
March 22, 2018. Oral presentations from the public will be scheduled on 
March 29 and 30, 2018, 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 
March 14, 2018. Time allotted for each presentation may be limited. If 
the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled

[[Page 8886]]

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 March 15, 2018.
    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 [email protected], 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 website at https://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: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04167 Filed 2-28-18; 8:45 am]
BILLING CODE 4164-01-P