FDA Classifies Breast Implant Suction Retrieval Systems as Class II Devices
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This rule puts breast implant suction retrieval systems into FDA class II, meaning they can be marketed under special safety and performance controls instead of facing the stricter class III premarket approval path. The device is used in medical procedures to help remove breast implants through suction retrieval. The change matters for medical device makers, surgeons, hospitals, and patients because it creates a clearer and less burdensome regulatory route while still requiring controls meant to protect safety and effectiveness. Manufacturers will need to meet the FDA’s class II special controls for this device type.
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Key Changes
- Classifies breast implant suction retrieval systems as class II medical devices
- Applies special FDA controls for safety and effectiveness
- Reduces the regulatory burden compared with automatic class III treatment
Obligations
What this law requires
Manufacturers of breast implant suction retrieval systems must comply with FDA class II special controls applicable to this device type before marketing the device in the United States.