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# Workshop on Spinal Device Clinical Reviews
- URL: https://www.fdaweb.com/workshop-on-spinal-device-clinical-reviews/
- Published: 2021-06-07T12:00:00.000Z
- Updated: 2026-09-14T17:02:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149482

FDA has announced a 9/17 virtual public workshop entitled “Spinal Device Clinical Review.” The workshop is intended to clarify FDA’s approach to clinical review of spinal devices falling under 21 CFR Part 888\. It will also address the major elements that the agency assesses in its review of spinal device clinical data submissions.

The workshop is not intended to communicate any new policies, processes or interpretations about medical device marketing authorizations, an FDA notice says. “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,” it says.