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  4. September 8-9, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 09/08/2020 - 09/09/2020
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Event Title
September 8-9, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
September 8 - 9, 2020


Date:
September 8 - 9, 2020
Day1:
- ET
Day2:
- ET

Center Date Time Location
CDRH September 8, 2020
September 9, 2020
8:00 a.m. - 6:00 p.m.
8:00 a.m. - 1:00 p.m.
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.

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.

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, 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 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 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 fdaoma@fda.hhs.gov 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 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:  July 23, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.


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 or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).


Event Materials

Title File Type/Size Source Organization
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - North Jersey Orthopaedic Institute letter pdf (74.88 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - NSPC letter pdf (180.92 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Chernoff letter pdf (69.34 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Leversedge letter pdf (158.20 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Yale Orthopaedics and Rehabilitation letter pdf (126.66 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Ammerman letter pdf (23.47 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Atlantic Health System letter pdf (630.44 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Welch letter pdf (20.03 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Duke Orthopaedic Surgery letter pdf (208.84 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Texas Back Intitute letter pdf (946.99 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Chen letter pdf (58.37 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Obedian letter pdf (1.88 MB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Koutsoumbelis letter pdf (350.11 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - ASPIRUS letter pdf (484.02 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Regulatory Reference Sheet (Bone Growth Stimulators) pdf (89.59 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Regulatory Reference Sheet pdf (104.72 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Questions (Intracompartmental Pressure Monitor) pdf (90.08 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Questions (Bone Growth Stimulators) pdf (68.34 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Questions (Metatarsophalangeal) pdf (141.28 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Questions (Intra-Abdominal Pressure Monitoring) pdf (82.61 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Questions (Facet Screw) pdf (84.66 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Intracompartmental Pressure Monitor Executive Summary pdf (370.88 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Bone Growth Stimulators Executive Summary pdf (670.59 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Metatarsophalangeal Joint Implants Executive Summary pdf (680.67 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Intra-Abdominal Pressure Monitoring Executive Summary pdf (230.14 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Facet Screw Executive Summary pdf (141.62 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Agenda pdf (133.57 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - WebCast Link pdf (1.02 MB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8, 2020 - Roster pdf (77.03 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 9, 2020 - Roster pdf (81.56 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Univ. of Colorado Letter pdf (147.61 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - MDMA letter pdf (543.63 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - Spine Specialists of Boston pdf (895.55 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8-9, 2020 - BGS Coalition pdf (6.90 MB) Non-FDA
ORDP Sept. 8, 2020 - FDA Presentation Proposed Classification of Facet Screws pdf (992.41 KB) FDA
ORDP Sept. 8, 2020 - FDA Presentation Device Classification pdf (1,004.24 KB) FDA
ORDP Sept. 9, 2020 - FDA Presentation Proposed Classification of Toe Prothesis pdf (1.10 MB) FDA
ORDP Sept. 8, 2020 - FDA Presentation Proposed Reclassification of Non-Invasive Bone Growth Stimulator pdf (1.65 MB) FDA
ORDP Sept. 9, 2020 - Classification of Intra-Abdominal Pressure Monitoring Devices pdf (410.28 KB) FDA
ORDP Sept. 9, 2020 - FDA Presentation Proposed Classification of Intracompartmental Pressure pdf (1.05 MB) FDA
ORDP Sept. 8-9, 2020 - ASA Reclassification Letter pdf (188.58 KB) Non-FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 8, 2020 - 24 Hour Summary pdf (129.70 KB) FDA
Orthopaedic and Rehabilitation Devices Panel Sept. 9, 2020 - 24 Hour Summary pdf (168.67 KB) FDA

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