FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CARDIOVASCULAR DEVICES; CLASSIFICATION OF THE INFANT PULSE RATE AND OXYGEN SATURATION MONITOR FOR OVER-THE-COUNTER USE

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use.

The rule was published in the Federal Register on Oct. 9 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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-co...