FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE SIMPLE IN VITRO DIAGNOSTIC DEVICE FOR THE DETECTION OF SECRETED PROTEINS FROM BACILLUS SPECIES (SPP.) IN HUMAN CLINICAL SAMPLES

WASHINGTON, June 22 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples.

The rule was published in the Federal Register on June 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillusspecies (spp.) in human clinical samples into class II (special controls). The special controls that apply to the device type are identified in this order and wil...