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 Classification of Non-Microbial Analyte Detection Devices
$9.99
Dive into the intricacies of the FDA’s new rule classifying devices designed to detect and measure non-microbial analytes. Learn about the special controls required for class II classification and how these changes can affect device manufacturers and healthcare professionals. This course equips you with the necessary insights to ensure compliance and leverage the reduced regulatory burdens to enhance patient access to innovative devices.
In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of these devices.
* Identify the key requirements and special controls associated with class II classification.
* Recognize the implications for device manufacturers and the healthcare industry.
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; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections. Document Number: 2025-08144 |
|---|---|
| Course SKU | FR-25-1328-1 |
| Why This Course Is Important | Failing to understand and apply the new special controls could lead to compliance issues, regulatory setbacks, and missed opportunities in device innovation. |