Stay ahead in the medical device industry with this targeted training on FDA’s final rule for foam or gel chemical sterilant/high level disinfectants. Learn the specific requirements for Class II classification, including essential special controls, performance testing, labeling standards, and the 510(k) submission process. Gain step-by-step guidance for regulatory compliance, protecting both your business and patient safety while enabling market access for innovative infection control products.
In this course you will learn the following:
* Understand the new classification and regulatory requirements for foam or gel chemical sterilant/high level disinfectants.
* Identify the special controls and general controls applicable to these devices.
* Implement the necessary steps to ensure compliance with the final rule.
* Recognize the legal and financial risks of non-compliance.
