FDA classifies breast implant suction retrieval system as Class II device

The Food and Drug Administration has officially classified a specific medical tool, called the breast implant suction retrieval system, into Class II. This classification means the agency believes general safety rules plus some extra specific controls are enough to ensure the device works safely and effectively.

Why it matters: This is primarily an administrative update that clarifies how regulators view a specific surgical tool. It does not approve any single brand but establishes the rules for this category of device. The practical effect is that future manufacturers may face less red tape and lower costs to get similar suction retrieval tools onto the market, potentially increasing access for patients and surgeons.

Who it affects

• Medical device manufacturers who make or plan to make breast implant removal tools

---

This information comes from a final order published by the Food and Drug Administration in the Federal Register on April 20, 2023; readers should consult the original document for full regulatory details.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document