ARTICLE
19 October 2015

FDA Classifies Oral Electronic Vision Aid

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Jones Day

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In the September 22, 2015, Federal Register, FDA announced the classification of the oral electronic vision aid into class II (special controls).
United States Food, Drugs, Healthcare, Life Sciences

In the September 22, 2015, Federal Register, FDA announced the classification of the oral electronic vision aid into class II (special controls). FDA is requiring labeling, performance testing, software verification, and other methods to mitigate the identified risks, such as adverse tissue malfunctions, electrical shock, and software malfunction.

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