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In the November 17, 2015, Federal Register, FDA issued a reproposal of a proposed rule to classify IVD devices for Bacillus species (spp.) detection into class II (special controls)...
United StatesFood, Drugs, Healthcare, Life Sciences
In the November 17, 2015, Federal Register, FDA issued a reproposal of a
proposed rule to classify IVD devices for Bacillus species (spp.)
detection into class II (special controls) after considering, among
other information, the recommendations of the Microbiology Devices
Advisory Panel. In addition, FDA is again proposing to restrict use
and distribution of the devices. Comments are due February 16,
2016.
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