$19.99
Stay current with the latest FDA requirements for temperature regulation devices used in esophageal protection during cardiac ablation procedures. This course guides medical device professionals through the new class II classification, special controls, performance testing, labeling, and 510(k) premarket notification steps. Learn what’s required for regulatory compliance, market access, and patient safety, and avoid the legal and financial risks associated with non-compliance under the FDA’s final rule.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying these devices as class II.
* Identify the special controls and general controls applicable to these devices.
* Recognize the steps required for compliance, including performance testing, labeling, and premarket notification.
* Appreciate the legal and regulatory consequences of failing to comply with the new classification and controls.
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 crucial compliance steps, jeopardizing device approval, facing regulatory penalties, and experiencing costly delays in market entry.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures.
Key regulatory references include:
Course SKU
FR-26-2198-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance. Document Number: 2026-22380
Buy this Course
FR-26-3302-1
Why This Course is Important
Without this course, organizations risk non-compliance, potential loss of HHS funding, increased legal exposure, and confusion among staff and stakeholders about disability definitions and regulatory obligations.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance.
Key regulatory references include:
Course SKU
FR-26-3302-1
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