In the July 1, 2016, Federal Register, the FDA released a proposed rule that would require certain data elements be submitted in the Automated Commercial Environment or any other CBP-authorized electronic data interchange system. The requirement would apply to information material to the admissibility determination for FDA-regulated products being imported or offered for import. This proposed action would facilitate automated "may proceed" determinations for low-risk FDA-regulated products, and it would allow the Agency to focus its resources on products that may be associated with a greater public health risk. Comments are due August 30, 2016.
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