$19.99
Stay up to date on the FDA’s classification and regulatory requirements for skin patch devices intended to treat hyperhidrosis. This course covers the specifics of the final rule under 21 CFR 878.4425, including compliance strategies for manufacturers and sponsors. Learn about special controls, essential performance testing, labeling requirements, and the 510(k) process to ensure safe, effective, and market-ready products.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the skin patch for hyperhidrosis as a class II device.
* Identify the special controls and general controls applicable to this device type.
* Implement the required testing, labeling, and documentation to ensure compliance.
* 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
Without this training, you risk costly compliance errors, missed market opportunities, and potential regulatory action that could delay or prevent product launch.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis.
Key regulatory references include:
Course SKU
FR-26-2049-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants. Document Number: 2026-14509
Buy this Course
FR-26-2087-1
Why This Course is Important
Without this course, your organization risks non-compliance with updated CFTC rules, potential regulatory penalties, inefficient collateral practices, and missed opportunities for margin relief with seeded funds.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants.
Key regulatory references include:
Course SKU
FR-26-2087-1
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