Stay current with FDA requirements: this course details the new classification of the anchored esophageal sheath as a Class II medical device with special controls under 21 CFR 876.1510. Learn which performance, testing, and labeling requirements must be met, and discover the practical compliance steps essential for manufacturers and importers to avoid reclassification, recalls, or market removal. Designed for regulatory affairs professionals, quality managers, and device developers working with gastroenterology and urology devices.
In this course you will learn the following:
* Understand the FDA’s classification process for the anchored esophageal sheath.
* Identify the special controls and general controls required for compliance.
* Implement the necessary device performance, testing, and labeling requirements.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
