Stay ahead of regulatory changes with this targeted course on the FDA’s classification of the breast implant suction retrieval system as a class II device with special controls. Gain direct insight into the new compliance requirements, actionable steps for manufacturers, and critical deadlines. This training details performance testing, biocompatibility, labeling, 510(k) submissions, and the legal risks of non-compliance—ensuring you are prepared for the June 2026 enforcement date.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the breast implant suction retrieval system as class II.
* Identify the special controls and general controls applicable to this device type.
* Recognize the steps required for compliance, including premarket notification and performance testing.
* Appreciate the legal and regulatory consequences of failing to comply with the final rule.
