Document ID: FDA-2020-N-0008-0008
Agency: fda
Document Type: Notice
Title: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
Posted Date: 2020-02-24T05:00Z

[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10447-10448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03565]

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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 be held on April 23, 2020, from 8 a.m. to 6 
p.m. and on April 24, 2020, from 8 a.m. to 1 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Entrance for public meeting participants (non-FDA employees) is 
through Building 1 where routine security check procedures will be 
performed. For security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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. 5216, Silver Spring, MD 20993-0002, 
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 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 April 23, 2020, during session I, 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 recommendations regarding the 
reclassification of noninvasive 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 April 24, 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 
semiconstrained 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 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/CommitteesMeetingMaterials/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 
April 1, 2020. Oral presentations from the public will be scheduled on 
April 23, 2020, between approximately 8:15 a.m. and 8:45 a.m. and 
between approximately 1 p.m. and 1:30 p.m.; on April 24, 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

[[Page 10448]]

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 24, 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 March 25, 2020.
    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 Mallet at artair.mallett@fda.hhs.gov 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: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03565 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P