Stay current with the latest FDA regulation impacting over-the-counter (OTC) SARS-CoV-2 tests. This course details the new classification of these COVID-19 tests as class II devices, the specific special controls manufacturers must implement, labeling mandates, design and validation requirements, and actionable compliance steps. Essential for device manufacturers, regulatory professionals, and laboratories aiming to maintain market access and ensure public health safety under the new federal rule.
In this course you will learn the following:
* Understand the FDA’s classification process for OTC SARS-CoV-2 tests.
* Identify the special controls and general controls applicable to these devices.
* Implement the required labeling, design, validation, and reporting measures.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
