FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF A MULTIPLEX RESPIRATORY PANEL TO DETECT AND IDENTIFY EMERGING RESPIRATORY PATHOGEN(S) AND COMMON RESPIRATORY PATHOGENS IN HUMAN CLINICAL SPECIMENS

WASHINGTON, Aug. 21 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens.

The rule was published in the Federal Register on Aug. 21 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens into class II (special controls). The special controls that apply to ...