FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE TO DETECT AND IDENTIFY MICROBIAL NUCLEIC ACIDS BY FLUORESCENCE IN SITU HYBRIDIZATION IN CLINICAL SPECIMENS

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens.

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

Summary: The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part...