LEGISLATION TO ELIMINATE FDA EXPORT APPROVAL FOR CERTAIN DEVICES TO BE REINTRODUCED NEXT YEAR; SHALALA NOTES NEED FOR STATUTORY CHANGES
This article was originally published in The Gray Sheet
Executive Summary
Rep. Jay Kim (R-Calif.) plans to reintroduce a bill in the 104th Congress that would eliminate FDA export approval requirements for unapproved devices being shipped to countries with established device approval systems.