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FDA Rule on Hydrophilic Re-Coating Solution Classification
$9.99
Dive into the FDA’s new classification for hydrophilic re-coating solutions, designed to enhance the safety and market accessibility of ophthalmic devices. This course will guide you through the special controls mandated by the FDA, ensuring you understand the necessary compliance measures to maintain device safety and effectiveness. Grasp the regulatory nuances and gain insights into the potential market impacts.
In this course you will learn the following:
* Understand the classification process and criteria for the hydrophilic re-coating solution.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.
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”.
Additional information
| Federal Register Title | Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution. Document Number: 2024-19882 |
|---|---|
| Course SKU | FR-24-237-1 |
| Why This Course Is Important | You could miss critical insights into FDA compliance strategies necessary to maintain market access and ensure patient safety, risking costly delays and non-compliance issues. |