FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE TO DETECT AND IDENTIFY MICROORGANISM NUCLEIC ACIDS AND RESISTANCE MARKERS FROM PATIENTS WITH SUSPECTED ORTHOPEDIC INFECTION

WASHINGTON, May 12 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection.

The rule was published in the Federal Register on May 12 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection into class II (special controls). The special controls that apply to the device type are identified in this order an...