$129.99
Stay informed on the FDA’s proposed rule to classify blood irradiator devices, which sets a new regulatory standard for preventing transfusion-associated graft-versus-host disease and metastasis. This course delivers practical insight into device classification, premarket approval, special controls, and the critical safety measures expected of manufacturers and healthcare organizations. Learn what these changes mean for compliance, device safety, and future product development.
In this course you will learn the following:
* Understand the purpose and goals of the proposed rule for blood irradiation devices.
* Identify the key safety and operational concerns addressed by the rule.
* Recognize the process for submitting public comments and participating in the rulemaking process.
* Describe the device classification and regulatory requirements proposed.
* Appreciate the evolving nature of the rule and the impact of stakeholder feedback.
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 key regulatory changes, which could lead to non-compliance, gaps in device safety protocols, and a lack of preparedness for upcoming FDA requirements.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Radiology Devices; Classification of Blood Irradiators.
Key regulatory references include:
Course SKU
FR-26-1807-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment. Document Number: 2026-11526
Buy this Course
FR-26-1987-1
Why This Course is Important
Without this course, practitioners risk non-compliance with updated DEA rules, potential loss of prescribing privileges, audit failures, and exposure to significant legal and financial penalties.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment.
Key regulatory references include:
Course SKU
FR-26-1987-1
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