Preload of Generic Software Precludes Finding of Substantial Transformation in U.S. When Replaced with Proprietary Software That Enhanced Functionality
Client Alert | less than 1 min read | 05.31.16
Customs and Border Protection has released its final determination concerning different versions of certain network transceivers and high speed cabling devices that require software to be functional. CBP concluded that “blank” network transceivers imported into the U.S. where proprietary software was first downloaded were substantially transformed in the U.S., whereas network transceivers already programmed with generic software when imported were not substantially transformed by subsequent replacement of the generic software with proprietary software that enhanced and broadened functionality allowing interoperability with different OEM systems.
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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