WASHINGTON, May 6 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device.
The rule was published in the Federal Register on May 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the circulating tumor cell enrichment device 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 circulating tumor cell enrichment device. We are taking this action because we have determined that classifying the ...