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Various testing measures and labeling will be required to mitigate the identified risks of adverse tissue reaction, ineffective marking, and improper use.
United StatesFood, Drugs, Healthcare, Life Sciences
In the August 5, 2015, Federal Register, FDA
announced the classification of the Internal Tissue Marker into
class II (special controls). Various testing measures and labeling
will be required to mitigate the identified risks of adverse tissue
reaction, ineffective marking, and improper use.
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