Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Rule: Class II Classification for Breast Implant Suction Retrieval Systems
$19.99
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.
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”.
Why This Course is Important
Without this course, you risk missing essential steps for FDA compliance—potentially leading to enforcement actions, delayed market access, and costly penalties.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System.
Key regulatory references include:
Course SKU
FR-26-2035-1