Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
Key claim: The FDA is classifying the breast implant suction retrieval system as a Class II medical device subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the breast implant suction retrieval system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for the breast implant suction retrieval system, meaning future manufacturers can market similar devices via 510(k) rather than the more burdensome premarket approval route. For patients and surgeons, it formalizes safety and effectiveness expectations for a device used in breast implant removal procedures.