Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
FDA Class II Classification: Breast Milk Macronutrients Test System
$9.99
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.
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”.
Additional information
| Federal Register Title | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System. Document Number: 2025-08147 |
|---|---|
| Course SKU | FR-25-1322-1 |
| Why This Course Is Important | Without this course, you may miss vital insights into complying with new FDA regulations and leveraging the De Novo classification to enhance patient access. |