Federal Register #FDA-2026-N-6709

FDA Classifies Breast Implant Suction Retrieval System and Chemical Sterilant as Class II Medical Devices

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final regulatory order classifying two medical devices as Class II with special controls: - Government Buyer - Department of Health and Human Services - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - Devices Classified - Breast implant suction retrieval system - Prescription surgical device using vacuum suction to remove and contain ruptured silicone breast implants - Subject to special controls including: - Animal performance testing - Non-clinical performance testing - Sterility and shelf life testing - Biocompatibility evaluation - Usability testing - Specific labeling requirements (device specifications, compatible implant sizes/types) - Foam or gel chemical sterilant/high level disinfectant - Intended for sterilization and high-level disinfection - Classified with special controls to ensure safety and effectiveness - OEMs and Vendors - No specific OEMs or vendors are named as manufacturers in this classification action - Notable Requirements - Devices must meet rigorous testing and labeling standards to ensure safety and effectiveness - Classification aims to reduce regulatory burdens while maintaining safety - Procurement Details - This is a regulatory classification notice, not a procurement or solicitation for products or services

Description

The Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system into class II (special controls). This classification provides reasonable assurance of safety and effectiveness for the device, which is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant. The special controls include requirements for animal performance testing, non-clinical performance testing, sterility, shelf life, biocompatibility, usability testing, and specific labeling. This action aims to enhance patient access to innovative devices by reducing regulatory burdens and is effective as of June 26, 2026, with classification applicable from April 20, 2023.

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