$129.99
Stay ahead in oncology diagnostics with this detailed course on the FDA’s proposed rule to reclassify nucleic acid-based test systems used with approved oncology therapeutic products. Learn about the transition from class III to class II, the regulatory background, device requirements, rationale for change, and the special controls FDA proposes to ensure safety and effectiveness. Gain insight into risks, benefits, and the significant impact on patient access, innovation, and compliance. Equip yourself with knowledge to respond proactively to regulatory changes and participate in the public comment process.
In this course you will learn the following:
* Explain the purpose and intent of the FDA’s proposed reclassification.
* Describe the regulatory framework for medical device classification.
* Identify the types of devices affected by the proposed rule.
* Summarize the rationale and data supporting the proposed reclassification.
* Recognize the risks to health and the proposed special controls to mitigate them.
* Understand the process and importance of public participation in the rulemaking.
* Acknowledge that the rule is not final and may change based on public input.
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 may miss critical updates on FDA regulatory changes impacting oncology test systems—risking gaps in compliance, missed opportunities for patient access, and a lack of preparedness for new device requirements or public participation.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments.
Key regulatory references include:
Course SKU
FR-25-1604-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare Program; Updates to the Master List of Items Potentially Subject to Face to Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List. Document Number: 2026-00487
Buy this Course
FR-26-1672-1
Why This Course is Important
Missing this course could result in denied claims, costly audits, and compliance failures that disrupt patient access and jeopardize Medicare reimbursements.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare Program; Updates to the Master List of Items Potentially Subject to Face to Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List.
Key regulatory references include:
Course SKU
FR-26-1672-1
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