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In the October 27, 2015, Federal Register, FDA issued a final order classifying an autosomal recessive carrier screening gene mutation detection system into class II (special controls).
United StatesFood, Drugs, Healthcare, Life Sciences
In the October 27, 2015, Federal Register, FDA issued a final order
classifying an autosomal recessive carrier screening gene mutation
detection system into class II (special controls). The special
controls that apply to this device are identified in this order and
will be part of the codified language for the autosomal recessive
carrier screening gene mutation detection system classification.
The order is effective immediately.
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