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FDA’s Class II Classification of Microbial Nucleic Acid Devices
$19.99
Gain a comprehensive understanding of the FDA’s recent classification of microbial nucleic acid storage and stabilization devices into Class II with special controls. This course highlights the significance of these controls in ensuring device safety and effectiveness, while also reducing regulatory burdens. Equip yourself with the knowledge to navigate this regulatory shift and enhance access to innovative medical solutions.
In this course you will learn the following:
* Understand the classification process and criteria for the microbial nucleic acid storage and stabilization device.
* Identify the special controls required for compliance.
* Recognize the impact of this classification on regulatory burdens and patient access to innovative devices.
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 Microbial Nucleic Acid Storage and Stabilization Device. Document Number: 2025-08145 |
|---|---|
| Course SKU | FR-25-1329-1 |
| Why This Course Is Important | Participants will miss crucial insights into navigating FDA's Class II classification, which could impact compliance and market access for microbial nucleic acid devices. |