FDA streamlined export procedures should cover additional device categories, HIMA says.
This article was originally published in The Gray Sheet
Executive SummaryDEVICE EXPORT STREAMLINING REG SHOULD APPLY TO PENDING PMA SUPPLEMENTS that do not include clinical data, the Health Industry Manufacturers Association states in Feb. 12 comments on FDA's proposal to ease export requirements for investigational devices. HIMA points out that modifications to devices with approved premarket approval applications "often proceed through a PMA supplement without the necessity of an approved" investigational device exemption for gathering clinical data; however, a product must have an IDE to be eligible for the streamlined export procedures outlined in FDA's Nov. 27 proposed rule.
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