[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54359-54360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1726]


Circulatory System 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 Circulatory System 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 December 4 and 5, 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 telephone number 
is 301-977-8900; additional information available online at: https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html. 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 20993-0002, 
[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 December 4, 2018, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator 
device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind 
device is indicated to provide cardiac contractility modulation for 
class III heart failure patients who are not responding to optimal 
medical therapy.
    On December 5, 2018, the committee will discuss and make 
recommendations regarding issues relating to the emergence of medical 
devices, which aim to treat hypertension. Currently, clinical studies 
to evaluate the safety and effectiveness of these devices are 
progressing. FDA requests panel input regarding the potential 
indications and labeling for devices intended to treat hypertension and 
optimal study designs needed to

[[Page 54360]]

evaluate the potential benefits and risks while considering issues such 
as medication compliance, patient perspective, and appropriate study 
controls.
    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: FDA will work with affected industry, professional 
organizations, and societies with an interest in medical devices 
designed to treat hypertension, as well as members of those groups who 
wish to make a presentation separate from the general open public 
hearing; time slots are available on December 5, 2018. Representatives 
from industry, professional organizations and societies interested in 
making formal presentations to the committee should notify the contact 
person on or before November 13, 2018.
    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 November 21, 
2018. Oral presentations from the public will be scheduled on December 
4 and 5, 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 November 13, 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 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 November 14, 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 Artair Mallett at [email protected] or 301-796-9638 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: October 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23577 Filed 10-26-18; 8:45 am]
 BILLING CODE 4164-01-P


