FDA classifies noise-canceling systems for infant incubators as Class II devices
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Table of Contents
The Food and Drug Administration (FDA) is changing how it categorizes active noise attenuation systems used in infant incubators. These are devices designed to reduce sound levels around infants in hospital settings.
Why it matters: This is an administrative change that clarifies the regulatory pathway for manufacturers of noise-canceling equipment used in neonatal care.
Who it affects
- Manufacturers of medical devices that use active noise reduction in infant incubators
This information comes from the FDA via the Federal Register; readers should consult the official document before making regulatory or business decisions.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document