Stakeholders Argue Over Deadline For Marking Of Reprocessed Devices
This article was originally published in The Gray Sheet
Executive Summary
Senators Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) say FDA is misinterpreting deadlines for recently enacted device marking provisions
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Starting in three months, reprocessors will have to prominently and conspicuously identify themselves on or near all single-use devices they reprocess, even if the products were not branded by their original manufacturers
Reprocessors Have Three Months To Mark Devices; Guidance Tells Them How
Starting in three months, reprocessors will have to prominently and conspicuously identify themselves on or near all single-use devices they reprocess, even if the products were not branded by their original manufacturers
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Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...