FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE ANTI-PHOSPHOLIPASE A2 RECEPTOR IMMUNOLOGICAL TEST SYSTEM

WASHINGTON, Aug. 21 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System.

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 anti-phospholipase A2 receptor immunological test system 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 the anti-phospholipase A2 receptor immunological test system's classification. We a...