VASCULAR GRAFT TRACKING ELIMINATION OF "RECEIPT" VERIFICATION REQUIREMENT
This article was originally published in The Gray Sheet
Executive Summary
VASCULAR GRAFT TRACKING ELIMINATION OF "RECEIPT" VERIFICATION REQUIREMENT is sought by Impra in a March 7 request to FDA for variance from tracking requirements. Impra wishes to eliminate the pre-implantation tracking regulation requirements of receipt verification and collection of other distributor information, and instead concentrate on collection of "implant" data after the device has been implanted. By this method, Impra maintains, the company will avoid having to track grafts that, when implanted, do not fit the regulatory definition of trackable devices.
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