---
kind: "section"
citation: "21 C.F.R. § 878.4675"
title: "21"
number: "878.4675"
heading: "Breast implant suction retrieval system."
url: "https://uscodex.org/cfr/21/878.4675"
---

# §878.4675. Breast implant suction retrieval system.

- (a) **Identification.** A breast implant suction retrieval system is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Animal performance testing must demonstrate that the device performs as intended and will not result in tissue injury. Testing must:
    - (i) Demonstrate the ability to remove implants of the sizes and types specified in device labeling; and
    - (ii) Assess tissue integrity and injury at multiple time intervals to assess tissue healing response after device use.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
    - (i) Characterization of the range of device operation, including minimum and maximum vacuum suction parameters;
    - (ii) Durability and integrity testing; and
    - (iii) **Characterization of control and variation of suction application.**
  - (3) Performance testing must demonstrate the sterility of the device.
  - (4) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (5) The tissue-contacting components of the device must be demonstrated to be biocompatible.
  - (6) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the directions for use.
  - (7) Labeling must include the following:
    - (i) Summary of device specifications, including vacuum suction pressure ranges and bottle capacity; and
    - (ii) **Sizes and types of implants that can be removed with the device.**

## Notes

### Amendments

[91 FR 38503, June 26, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[91 FR 38503, June 26, 2026]