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  5. Virtual Public Workshop - Spinal Device Clinical Review - 09/17/2021 - 09/17/2021
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Meeting

Event Title
Virtual Public Workshop - Spinal Device Clinical Review
September 17, 2021

Date:
September 17, 2021
Time:
9:00 AM - 4:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled "Spinal Device Clinical Review." This workshop is intended to enhance public understanding of FDA's approach to clinical review of spinal devices falling under 21 CFR Part 888. The purpose of the workshop is to provide information to our stakeholders, including members of the orthopedic community, device manufacturers, regulatory affairs professionals, clinicians, patients and the general public, regarding FDA regulations, guidances and regulatory pathways related to spinal device clinical review.

Background

This public workshop is intended to provide information pertaining to FDA's clinical review of spinal devices regulated under 21 CFR Part 888. The goal is to provide an overview of spinal devices and a summary of the major elements that FDA assesses in its review of spinal device clinical data submissions. The public workshop is not intended to communicate any new policies, processes or interpretations regarding medical device marketing authorizations. The topics for discussion will cover spinal device types, non-clinical performance testing, major types of clinical evidence, study populations, strategies to enhance diversity in spinal device clinical trials, patient assessments, and methods for evaluating spinal device safety and effectiveness. Discussions involving external subject matter experts will cover topics related to spinal device studies including defining a target population, study enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments.

DATE and TIME

This meeting will be held September 17, 2021 from 9:00 a.m. to 4:00 p.m. ET by webcast only.

WEBCAST WORKSHOP LINK

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email if you registered. The link for archived webcast will be posted to this webpage for viewing after the public workshop.

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

TIME TOPIC PRESENTER
9:00-9:15 a.m. Welcome and Opening Remarks CAPT Raquel Peat, PhD, MPH, FDA
Master of Ceremony: TBD
9:05-9:20 a.m. Scientific Discussion - The Role and Limits of Non-Clinical Performance Testing of Spinal Devices TBD
9:20-9:30 a.m. Industry Perspectives on Non-Clinical Performance Testing TBD
9:30-9:50 a.m. Overview of Spinal Device Clinical Review – Types of Clinical Evidence, Patient Selection, Patient Assessments, Evaluation of Device Safety and Effectiveness TBD
9:50-10:00 a.m. Break
10:00–10:15 a.m. Strategies for Enhancement of Diversity in Spinal Device Clinical Trials TBD
10:15–11:05 a.m. Clinical Discussion – Defining A Target Population, Enrollment Criteria, and Strategies for Inclusion of Under-Represented Groups TBD
11:05-11:15 a.m. Industry Perspectives on Spinal Device Clinical Trials TBD
11:15-11:45 a.m. Q & A Session TBD
11:45-12:45 p.m. Lunch Break
12:45-12:55 p.m. Audience Survey TBD
12:55-1:45 p.m. Clinical Discussion – Evaluation of Safety for Spinal Devices: Adverse Events and Evaluation of Subsequent Surgical Procedures TBD
1:45-2:15 p.m. Q & A Session TBD
2:15-2:30 p.m. Break
2:30-3:20 p.m Clinical Discussion – Evaluation of Effectiveness for Spinal Devices: Clinical Study Endpoints, Clinical Outcome Assessments  and Imaging Outcomes TBD
3:20-3:50 p.m. Q & A Session TBD
3:50-4:00 p.m. Closing Remarks TBD

REGISTRATION

If you wish to attend this workshop, you must register by 4:00 p.m. on September 15, 2021. There is no fee to register for the workshop. Registration will be on a first-come, first-served basis.

No dashes or spaces in phone numbers please.
 

Registrants will receive confirmation when requests for participation have been accepted, if applicable.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, Peggy.Roney@fda.hhs.gov by September 3, 2021

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2021-N-0524 October 18, 2021.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received. The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content please contact:

LCDR Ogochukwu Ogoegbunam
Regulatory Health Project Manager
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
240-402-2573
OHT6-Feedback@fda.hhs.gov
CDRHpublicmeetings@fda.hhs.gov

REFERENCES

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