FDA Rule on Hydrophilic Re-Coating Solution Classification

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.