FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF THE RADIOLOGICAL ACQUISITION AND/OR OPTIMIZATION GUIDANCE SYSTEM

WASHINGTON, June 2 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System.

The rule was published in the Federal Register on June 2 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 radiological acquisition and/or optimization guidance 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 radiological acquisition and/or optimization guidance system's classification. We are takin...