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 Classification and Special Controls for SARS-CoV-2 Serology Tests
$19.99
Ensure your team is fully up-to-date on the FDA’s final rule reclassifying SARS-CoV-2 serology tests as class II devices with special controls. This targeted course equips manufacturers, compliance officers, and laboratory leaders with actionable steps to meet new regulatory obligations for COVID-19 antibody testing devices. Learn essential requirements on labeling, validation, 510(k) submissions, and emergency response protocols. Reduce regulatory burdens, minimize legal risks, and maintain market access through expert guidance on the latest FDA standards.
In this course you will learn the following:
* Understand the new classification of SARS-CoV-2 serology tests and the rationale behind it.
* Identify and implement the special controls required for compliance.
* Recognize the regulatory pathways and documentation required for marketing these devices.
* Understand the legal and financial 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, manufacturers and stakeholders risk missing critical updates on compliance deadlines, special controls, and documentation requirements—jeopardizing market access, exposing the business to enforcement actions, and potentially causing operational disruptions.
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 SARS-CoV-2 Serology Test.
Key regulatory references include:
Course SKU
FR-26-2036-1