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’s Classification of Cytomegalovirus Nucleic Acid Detection Device
$9.99
Explore the FDA’s recent classification of the cytomegalovirus nucleic acid detection device into Class II, highlighting the impact of special controls on safety and access. Gain insights into regulatory compliance and the benefits of reduced regulatory burdens, ensuring quicker access to innovative medical technologies.
In this course you will learn the following:
* Understand the classification process and criteria for the cytomegalovirus nucleic acid detection device.
* Identify the special controls and general controls applicable to the device.
* 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 Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection. Document Number: 2025-08146 |
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| Course SKU | FR-25-1325-1 |
| Why This Course Is Important | A comprehensive understanding of how the FDA's classification impacts regulatory compliance and access to innovative diagnostic tools, potentially leading to lost opportunities in leveraging these technologies effectively. |