WASHINGTON, June 1 -- Food and Drug Administration has issued a rule called: Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring.
The rule was published in the Federal Register on June 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring 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 rigid sterilization container with electronic monitoring. We are taking this...