Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Medical Device Rule: OTC SARS-CoV-2 Test Classification & Special Controls
$19.99
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.
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”.
Why This Course is Important
Without this course, you risk missing vital compliance requirements, potentially resulting in regulatory penalties, loss of market access, or costly recalls due to non-compliance with FDA’s special controls.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens.
Key regulatory references include:
Course SKU
FR-26-2106-1