This course delivers targeted guidance on the FDA’s latest regulatory shift, classifying molecular diagnostic devices for vaginitis and bacterial vaginosis into class II with special controls. Get practical steps for compliance, actionable insights for manufacturers, and a clear overview of design, validation, and labeling obligations. Avoid costly setbacks by learning the details of the new regulatory expectations that support both patient safety and market access.
In this course you will learn the following:
* Understand the scope and intent of the FDA’s final classification order.
* Identify the key requirements and special controls for these devices.
* Implement the necessary steps to ensure compliance with the new classification.
* Recognize the legal and regulatory consequences of failing to comply.
