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 Class II Special Controls for Bacillus Species Diagnostic Devices
$19.99
This course offers a focused guide to the FDA’s rule classifying simple in vitro diagnostic devices for detecting secreted proteins from Bacillus species in human clinical samples as Class II with special controls. Learn actionable steps for compliance, including labeling, distribution, validation, and biosafety requirements, essential for manufacturers, laboratories, and regulatory professionals seeking to ensure device safety, legal distribution, and reliable performance in clinical settings.
In this course you will learn the following:
* Understand the scope and intent of the FDA’s final rule for these diagnostic devices.
* Identify the key requirements and special controls now enforceable by law.
* Implement the necessary steps to ensure compliance with the new classification and special controls.
* Recognize the legal and regulatory consequences of failing to comply with the 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 training, you risk missing vital details on regulatory requirements, special controls, and compliance steps, putting your organization at risk for recalls, penalties, or restricted market access.
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 Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples.
Key regulatory references include:
Course SKU
FR-26-2015-1