Remanufactured device premarket submissions would be due six months after CPG publication.
This article was originally published in The Gray Sheet
Executive Summary
REMANUFACTURED DEVICES' PREMARKET SUBMISSIONS DUE WITHIN SIX MONTHS of publication of an FDA compliance policy guidance on servicing/remanufacturing of used medical devices, according to a "trial balloon" version of the CPG recently floated by the agency. FDA unveiled the proposed CPG at a Sept. 29-30 meeting of the International Association of Medical Equipment Remarketers in Dallas.