[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45642-45643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16436]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Orthopaedic and Rehabilitation 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 Orthopaedic and Rehabilitation
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 take place virtually on September 8, 2020, from
8 a.m. to 6 p.m. Eastern Time and on September 9, 2020, from 8 a.m. to
1 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform held via
webcast only. Answers to commonly asked questions about FDA advisory
committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. The meeting
will be webcast both days and will be available at the following link:
Webcast link for Day 1: http://fda.yorkcast.com/webcast/Play/8ef8ac6b36f244beaced2a3031eebc621d.
Webcast link for Day 2: http://fda.yorkcast.com/webcast/Play/0e1b175674de4b1e8a4675cf5096aa601d.
FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, 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 the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On September
8, 2020, during session 1, the committee will discuss and make
recommendations regarding the classification of facet screws systems
which are currently unclassified pre-amendment devices to Class II
(general and special controls). During session II, the committee will
discuss and make
[[Page 45643]]
recommendations regarding the reclassification of non-invasive bone
growth stimulators which are currently post-amendment devices from
Class III (general controls and premarket approval) to Class II
(general and special controls).
On September 9, 2020, the committee will discuss and make
recommendations regarding the classification of three devices, which
are currently unclassified pre-amendment devices to class II (general
and special controls). The committee, during session I, will discuss
semi-constrained toe (metatarsophalangeal) joint prostheses; during
session II, will discuss intracompartmental pressure monitors; and
during session III, will discuss intra-abdominal pressure monitoring
devices.
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 on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/orthopaedic-and-rehabilitation-devices-panel.
Select the link for the 2020 Meeting Materials. The meeting will
include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
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
August 28, 2020. Oral presentations from the public will be scheduled
on September 8, 2020 between approximately 8:15 a.m. and 8:45 a.m. and
between approximately 1 p.m. and 1:30 p.m.; on September 9, 2020,
between approximately 8:15 a.m. and 9:15 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and indicate during which session they would like to
present (see FOR FURTHER INFORMATION CONTACT). The notification should
include 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 August 20, 2020. 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
sessions. The contact person will notify interested persons regarding
their request to speak by August 21, 2020.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
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 Mallet 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: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16436 Filed 7-28-20; 8:45 am]
BILLING CODE 4164-01-P