FDA Greenlights Noise-Canceling Baby Incubators as Class II
Published Date: 7/27/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators 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 active noise attenuation system for infant incubators. 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.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Reclassification Lowers Approval Burden
The FDA has classified active noise attenuation systems for infant incubators as Class II with special controls (codified at 21 CFR 880.5405). Because of the De Novo classification, this device type can serve as a predicate for future devices, letting other makers use the less-burdensome 510(k) pathway instead of a premarket approval application.
Device Remains Subject to 510(k) Notification
FDA states that active noise attenuation systems for infant incubators are subject to premarket notification under section 510(k) of the FD&C Act and have not been exempted under section 510(m). Manufacturers must submit a 510(k) to reasonably assure safety and effectiveness unless FDA later exempts the device type.
Mandatory Testing, Software, and Labeling Rules
FDA's special controls (21 CFR 880.5405) require manufacturers to perform non-clinical performance testing including verification/validation of acoustic parameters and attenuation performance, software validation and hazard analysis, electrical safety and electromagnetic compatibility testing, biocompatibility for patient-contacting parts, and specific labeling (instructions, warnings, cleaning, and compatible incubator IDs). These controls must be met for a device to fall into Class II.
Classification Aims to Improve Patient Access
FDA says classifying this device as Class II will provide reasonable assurance of safety and effectiveness and will enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. This change became effective July 27, 2026, and the classification was applicable on June 16, 2023.
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