Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
Key claim: The FDA is classifying over-the-counter infant pulse-rate and oxygen-saturation monitors as class II devices with special controls, so makers can bring them to market through a lighter 510(k) pathway rather than full premarket approval.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use 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 infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.
Why this matters
Classifying OTC infant pulse-rate and oxygen-saturation monitors as Class II with special controls lowers the regulatory bar for manufacturers to market consumer baby monitors by using 510(k) notification instead of full premarket approval. This is a routine but consequential step in FDA’s device-classification work, shaping what home-use infant monitoring products reach parents and under what safety assurances.