$19.99
Stay current with FDA requirements: this course details the new classification of the anchored esophageal sheath as a Class II medical device with special controls under 21 CFR 876.1510. Learn which performance, testing, and labeling requirements must be met, and discover the practical compliance steps essential for manufacturers and importers to avoid reclassification, recalls, or market removal. Designed for regulatory affairs professionals, quality managers, and device developers working with gastroenterology and urology devices.
In this course you will learn the following:
* Understand the FDA’s classification process for the anchored esophageal sheath.
* Identify the special controls and general controls required for compliance.
* Implement the necessary device performance, testing, and labeling requirements.
* Recognize the legal and regulatory consequences of failing to comply with the final 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
Missing this course could mean overlooking critical compliance steps, leading to costly enforcement actions, product recalls, or loss of market access for your device.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath.
Key regulatory references include:
Course SKU
FR-25-1606-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction. Document Number: 2026-04797
Buy this Course
FR-26-1798-1
Why This Course is Important
Without this course, you risk missed reimbursement opportunities, non-compliance penalties, and operational setbacks as new Medicare regulations take effect in 2028.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction.
Key regulatory references include:
Course SKU
FR-26-1798-1
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