FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; HEMATOLOGY AND PATHOLOGY DEVICES; CLASSIFICATION OF THE FLUORESCENCE IN SITU HYBRIDIZATION-BASED DETECTION OF CHROMOSOMAL ABNORMALITIES FROM PATIENTS WITH HEMATOLOGIC MALIGNANCIES

WASHINGTON, June 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies.

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 fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this orde...