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Archive for the ‘Radiation Emitting Devices’ category

On December 19, 2014, the U.S. Food and Drug Administration issued a final guidance document regarding children’s toys that contain laser beams.  In the guidance, FDA defines children’s laser toys and offers suggestions for both the manufacturing and labeling of laser toys. FDA proposed a rule in June 2013 to define children’s laser toys and […]

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense.

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense.

(English) On September 6, 2011 the Food and Drug Administration issued a letter with recommendations to help expedite the entry review process for medical and non-medical radiation-emitting electronic products. In this letter the FDA has noted that Affirmation of Compliance (AofC) codes should be provided at the time of entry to the U.S. and that appropriately submitted AofC codes will not only expedite the admissibility process but will also increase the likelihood that your shipment is not held for further entry review by FDA personnel.

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