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Export streamlining covers significant, nonsignificant risk devices with IDEs -- FDA proposal.

This article was originally published in The Gray Sheet

Executive Summary

EXPORT OF INVESTIGATIONAL DEVICES WITHOUT FDA REVIEW will be allowed for both significant risk devices that have an approved investigational device exemption and nonsignificant risk products that do not require IDEs, the agency says in a proposed rule expected to be published in the Federal Register the week of Nov. 6. The proposal would allow devices that have approved IDEs to be exported to countries that say they will accept the products without FDA review.

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