FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF BLOOD IRRADIATORS

WASHINGTON, March 18 -- Food and Drug Administration has issued a proposed rule called: Medical Devices; Radiology Devices; Classification of Blood Irradiators.

The proposed rule was published in the Federal Register on March 18 by Robert F. Kennedy, Secretary, Department of Health and Human Services.

Summary: The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assu...