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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 […]

On August 12, 2013, the Director of the U.S. Food and Drug Administration’s (FDA) Division of Import Operations, Capt. Domenic Veneziano, requested that U.S. Customs and Border Protection (CBP) provide notification to FDA of all importations of visible and non-visible laser products (Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, […]

An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released […]

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.

Registrar Corp now provides Reporting, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Radiation-Emitting Electronic Device Industry. The U.S. FDA regulates Radiation-Emitting Electronic Devices intended for use in the United States by humans or other animals. U.S. FDA defines Radiation-Emitting Electronic Devices as “any product that contains an electronic circuit […]

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