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In the August 17, 2015, Federal Register, FDA announced it has classified the computerized cognitive assessment aid into class II (special controls) medical device.
United StatesFood, Drugs, Healthcare, Life Sciences
In the August 17, 2015, Federal
Register, FDA announced it has classified the
computerized cognitive assessment aid into class II (special
controls) medical device. Labeling and hardware and software
verification, validation, and hazard analysis will be required to
mitigate identified risks of equipment malfunction or incorrect
results.
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