Gain a comprehensive understanding of the FDA’s recent rule classifying infant pulse rate and oxygen saturation monitors for over-the-counter use as Class II medical devices. This course breaks down the mandatory special controls, compliance steps for manufacturers, and the critical performance, labeling, and safety standards required to bring these devices to market lawfully. Learn the exact obligations for 510(k) submissions, software validation, biocompatibility, and user safety that protect both infants and your business interests.
In this course you will learn the following:
* Understand the FDA’s classification process for new medical devices, specifically the De Novo pathway.
* Identify the key requirements and special controls for infant pulse rate and oxygen saturation monitors intended for OTC use.
* 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.
