FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE HERPES SIMPLEX VIRUS NUCLEIC ACID-BASED ASSAY FOR CENTRAL NERVOUS SYSTEM INFECTIONS

WASHINGTON, June 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections.

The rule was published in the Federal Register on June 26 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 herpes simplex virus nucleic acid-based assay for central nervous system infections 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 herpes ...