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
Webcast Workshop Link
Transcript
Agenda
Registration
Comments
Contact
References

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 to view it live is: https://fda.yorkcast.com/webcast/Play/1634e2b504e842a0976574a421e02dbc1d. The archived webcast is the same link. It will be available to view one week after the public workshop and remain active for one year.

TRANSCRIPT

Transcript for September 17th [PDF - 989 KB]

AGENDA

See biographies of the speakers [PDF - 7.6 MB]

Time	Title	Speaker
9:00 – 9:10	Welcome and Opening Remarks	CAPT Raquel Peat, PhD, MPH Director, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality (OPEQ), CDRH
*Master of Ceremony*- Christopher Harner, MD, Deputy Director, OHT6, OPEQ, CDRH
9:10 – 9:20	Scientific Discussion - The Role and Limits of Non-Clinical Performance Testing of Spinal Devices	Hassan Serhan, PhD University of Toledo
9:20 – 9:30	Industry Perspectives on Non-Clinical Performance Testing	Justin Eggleton, Vice President, Spine Regulatory Affairs MCRA, LLC
9:30 – 9:50	Overview of Spinal Device Clinical Review – Types of Clinical Evidence, Patient Selection, Patient Assessments, Evaluation of Device Safety and Effectiveness	Vincent J. Devlin, MD Chief Medical Officer, OHT6, OPEQ, CDRH
9:50 – 10:05	Strategies for Enhancement of Diversity in Spinal Device Clinical Trials	Elizabeth Adegboyega-Panox, MD Acting Deputy Director, OHT6, OPEQ, CDRH
10:05 – 10:15	Analysis of Diversity in Spinal Device Clinical Trials	Hongying Jiang, PhD, RAC Safety Signal Manager, OHT6, OPEQ, CDRH
10:15 – 10:25	Break
10:25 – 11:15	Clinical Discussion – Defining A Target Population, Enrollment Criteria, and Strategies for Inclusion of Under-Represented Groups *Topic Presenters*: Elizabeth Adegboyega-Panox, MD Caroline Moazzam, MD, and Dirk Alander, MD - Medical Officers, OHT6, OPEQ, CDRH	Paul Anderson, MD - University of Wisconsin Darrel Brodke, MD - University of Utah S. Raymond Golish, MD, PhD, MBA - HCA Healthcare JFK Hospital Khaled Kebaish, MD - Johns Hopkins University Noelle Larson, MD - Mayo Clinic
11:15 – 11:25	Industry Perspectives on Spinal Device Clinical Trials	Janice Hogan, JD Partner, Hogan Lovells US LLP
11:25– 11:55	Q & A Session Moderators: Vincent Devlin, MD, Chief Medical Officer, OHT6, OPEQ, CDRH and Ronald Jean, PhD, Director, DHT6B: Division of Spinal Devices, OHT6, OPEQ, CDRH
11:55 – 12:45	Lunch Break
12:45– 1:00	Audience Survey	Colin O’Neill, MBE Assistant Director, DHT6B, OHT6, OPEQ, CDRH
1:00 – 1:50	Clinical Discussion – Evaluation of Safety for Spinal Devices: Adverse Events and Evaluation of Subsequent Surgical Procedures *Topic Presenters*: Dirk Alander, MD and Barton Sachs, MD, MBA - Medical Officers, OHT6, OPEQ, CDRH	Paul Anderson, MD - University of Wisconsin Darrel Brodke, MD - University of Utah S. Raymond Golish, MD, PhD, MBA - HCA Healthcare JFK Hospital Khaled Kebaish, MD - Johns Hopkins University Noelle Larson, MD - Mayo Clinic
1:50– 2:20	Q & A Session Moderators: Vincent Devlin, MD, Chief Medical Officer, OHT6, OPEQ, CDRH, Ronald Jean, PhD, Director, DHT6B, OHT6, OPEQ, CDRH, and Jianxiong Chu, PhD, Acting Director, Division of Biostatistics, OCEA: Office of Clinical Evidence and Analysis
2:20 – 2:30	Break
2:30 – 3:20	Clinical Discussion – Evaluation of Effectiveness for Spinal Devices: Clinical Study Endpoints, Clinical Outcome Assessments and Imaging Outcomes *Topic Presenters*: Vincent Devlin, MD, Caroline Moazzam, MD, and Barton Sachs, MD - Medical Officers, OHT6, OPEQ, CDRH	Paul Anderson, MD - University of Wisconsin John Benson, MD – Mayo Clinic Darrel Brodke, MD - University of Utah S. Raymond Golish, MD, PhD, MBA - HCA Healthcare JFK Hospital Khaled Kebaish, MD - Johns Hopkins University Noelle Larson, MD - Mayo Clinic
3:20 – 3:50	Q & A Session Moderators: Vincent Devlin, MD, Chief Medical Officer, OHT6, OPEQ, CDRH, Ronald Jean, PhD, Director, DHT6B, OHT6, OPEQ, CDRH, and Jianxiong Chu, PhD, Acting Director, Division of Biostatistics, OCEA: Office of Clinical Evidence and Analysis
3:50 – 4:00	Closing Remarks	Ronald Jean, PhD, Director, DHT6B, OHT6, OPEQ, CDRH

REGISTRATION

Registration is closed.

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
[email protected]
[email protected]

REFERENCES

Guidance Document for the Preparation of IDEs for Spinal Systems (issued on January 13, 2000)
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff (issued on December 2, 2004)
Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs - Guidance for Industry and FDA Staff (issued on April 11, 2008)
Investigational Device Exemptions (IDEs) for Early Feasibility, Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and FDA Staff (issued on October 1, 2013)
Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, IRBs and FDA Staff (issued on November 7, 2013)
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and FDA Staff (issued on April 13, 2015)
Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff (issued on October 26, 2016)
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for IDE Sponsors, Sponsor-Investigations and FDA Staff (issued January 13, 2017)
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and FDA Staff (issued on August 31, 2017)
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - Guidance for Industry and FDA Staff (issued on September 12, 2017)
Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and FDA Staff (issued on February 21, 2018)
Breakthrough Devices Program - Guidance for Industry and FDA Staff (issued on December 18, 2018)
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and FDA Staff (issued on August 30, 2019)
Considerations of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Guidance for Industry and FDA Staff (issued on August 30, 2019)
Safer Technologies Program for Medical Devices - Guidance for Industry and FDA Staff (issued on January 6, 2021)