---
kind: "section"
citation: "21 C.F.R. § 880.5405"
title: "21"
number: "880.5405"
heading: "Active noise attenuation system for infant incubators."
url: "https://uscodex.org/cfr/21/880.5405"
---

# §880.5405. Active noise attenuation system for infant incubators.

- (a) **Identification.** An active noise attenuation system for infant incubators is a device system that captures environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing under anticipated conditions of use must demonstrate that the device performs as intended, including:
    - (i) Verification and validation of critical acoustic parameters, including the maximum output of the device;
    - (ii) **Verification and validation of the attenuation performance of the device, including—**
      - (A) Testing with compatible incubator model(s) and dimensions;
      - (B) Attenuation performance testing simulating different infant locations and orientations within the incubator; and
      - (C) **Testing with relevant noise sources and room configurations.**
  - (2) Software validation, verification, and hazard analysis must be performed.
  - (3) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device.
  - (4) The patient- or user-contacting components of the device must be demonstrated to be biocompatible.
  - (5) Labeling for the device must include:
    - (i) Instructions for infant placement and the expected attenuation performance of the device;
    - (ii) Warnings regarding the risks of exposure to the potential maximum output of the device;
    - (iii) Methods and instructions for cleaning and disinfection; and
    - (iv) **Identification of the incubator(s) that the device is intended to be used with.**

## Notes

### Amendments

[91 FR 46836, July 27, 2026]

### Authority

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

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[91 FR 46836, July 27, 2026]