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 New Classification for STI Diagnostic Devices
$9.99
Discover the FDA’s latest classification for devices detecting nucleic acids from non-viral microorganisms causing sexually transmitted infections. This course delves into the specifics of classifying these devices into class II with special controls, aiming to ensure safety and promote innovation while minimizing regulatory challenges. Gain insights into the regulatory landscape and its implications for device manufacturers, healthcare providers, and the broader healthcare industry.
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 healthcare providers.
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 Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s). Document Number: 2025-08149 |
|---|---|
| Course SKU | FR-25-1324-1 |
| Why This Course Is Important | Without this course, you might miss critical updates on FDA regulations affecting diagnostic devices for sexually transmitted infections, potentially leading to compliance issues or lost innovation opportunities. |