FDA Regulation: Spinal Imaging Systems for Neuraxial Procedures
Stay ahead of regulatory changes with training focused on the FDA’s classification of spinal imaging systems for neuraxial procedures. Learn how to comply with Class II (special controls) requirements, including performance testing, human factors, software validation, biocompatibility, sterility, and labeling. Discover actionable steps for 510(k) submissions and avoid enforcement risks. This course is essential for medical device manufacturers, regulatory professionals, and healthcare organizations working with spinal imaging systems in anesthesiology.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the spinal imaging system for neuraxial procedures as a class II device.
* Identify the special controls and general controls required for compliance.
* Outline the steps necessary to bring a spinal imaging system for neuraxial procedures to market under the new classification.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
