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 Class II Device Classification for Head and Neck Cancer Detection
$9.99
Gain critical insights into the FDA’s classification of devices detecting nucleic acid from viruses linked to head and neck cancers. This course covers the regulatory framework, compliance obligations, and the significance of the Class II classification. Equip yourself with the knowledge to navigate the FDA’s requirements and ensure your devices meet safety and effectiveness standards.
In this course you will learn the following:
* Understand the classification process and criteria for devices detecting nucleic acid from viruses associated with head and neck cancers.
* Identify the special controls and general controls applicable to these devices.
* Recognize the compliance requirements and deadlines for manufacturers.
* Comprehend the consequences of non-compliance with the FDA’s final rule.
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 or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers. Document Number: 2024-20896 |
|---|---|
| Course SKU | FR-24-224-1 |
| Why This Course Is Important | Without this course, learners risk non-compliance with FDA regulations, potentially leading to device market withdrawal and legal repercussions. |