FDA device export approval based on EU/Japan clearance proposed in legislation.
This article was originally published in The Gray Sheet
FDA DEVICE EXPORT APPROVAL BASED ON EUROPEAN/JAPANESE APPROVAL is proposed by Rep. Jay Kim (R-Calif.) in legislation introduced Jan. 11. The bill (HR 485) would streamline current FDA requirements for export of unapproved devices by directing the agency "to allow worldwide export of products which have received" approval in either the European Union or Japan, Kim said in a press release announcing the bill's introduction.
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