Gain in-depth knowledge of the FDA’s regulation process with our comprehensive course on the classification of endoscopic pancreatic debridement devices. Discover how the FDA’s Class II designation, with special controls, impacts device safety, effectiveness, and patient access to innovative medical technologies. Ideal for healthcare professionals involved in gastroenterology and medical device regulation, this course equips you with crucial insights into compliance and risk mitigation strategies.
In this course you will learn the following:
* Understand the classification process and criteria for medical devices.
* Identify the special controls applicable to the endoscopic pancreatic debridement device.
* Recognize the risks associated with the device and the mitigation measures required.
* Comprehend the regulatory requirements for compliance with the new classification.
