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.
