Gain a competitive edge with a thorough training on the FDA’s new class II classification for infant supine sleep systems. This course guides manufacturers, sponsors, and quality professionals through the detailed requirements for clinical data, human factors testing, biocompatibility, performance standards, labeling, and the 510(k) premarket notification process. Protect your business from costly recalls and legal penalties by understanding the FDA’s expectations for safety, effectiveness, and market authorization.
In this course you will learn the following:
* Understand the FDA’s classification process for the infant supine sleep system.
* Identify the special controls and general controls required for compliance.
* Outline the steps necessary to bring an infant supine sleep system to market.
* Recognize the legal and financial consequences of failing to comply with the final rule.
