$19.99
Stay ahead of critical regulatory shifts with this focused course on the FDA’s class II classification and special controls for laparoscopic gastrointestinal sizing tools. Learn exactly what manufacturers and importers must do to comply with new performance, biocompatibility, labeling, and sterility requirements. This training provides practical steps to maintain market access, avoid enforcement actions, and safeguard patient safety under the latest FDA rule.
In this course you will learn the following:
* Understand the FDA’s classification process for medical device accessories.
* Identify the key requirements and special controls for the laparoscopic gastrointestinal sizing tool.
* 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 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
Manufacturers and regulatory professionals who skip this course risk product delays, costly enforcement actions, and potential loss of market access for laparoscopic GI sizing tools due to non-compliance with the latest FDA requirements.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool.
Key regulatory references include:
Course SKU
FR-25-1483-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update. Document Number: 2026-06675
Buy this Course
FR-26-1848-1
Why This Course is Important
Without this course, you may miss important details on payment updates, new reporting requirements, and potential financial and compliance impacts for inpatient psychiatric facilities under Medicare in FY 2027.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update.
Key regulatory references include:
Course SKU
FR-26-1848-1
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