Discover the FDA’s recent classification of the breast milk macronutrients test system into Class II with special controls. This course will walk you through the essential regulatory requirements and the special controls that ensure both safety and innovation. Gain crucial insights into how these changes can enhance patient access to advanced nutritional testing and reduce regulatory burdens for medical device manufacturers.
In this course you will learn the following:
* Understand the classification process and criteria for the breast milk macronutrients test system.
* Identify the special controls required for compliance with the new classification.
* Recognize the benefits of the De Novo classification process in reducing regulatory burdens and enhancing patient access.
