- September 17, 2021
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.
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.
This meeting will be held September 17, 2021 from 9:00 a.m. to 4:00 p.m. ET by webcast only.
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.
This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
|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|
|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|
|2:30-3:20 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|
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.
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
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.
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
- 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)