ARTICLE
27 November 2015

FDA Issues Reproposal Of Proposed Rule To Classify Certain Diagnostic Devices For Bacillus Detection Into Class II

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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 States Food, 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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