Medtronic Warning Letter Clarifies FDA Expectations On MDRs And Recalls
This article was originally published in The Gray Sheet
Executive Summary
A recent FDA warning letter to Medtronic clarifies Medical Device Reporting requirements for consumer-reported adverse events and events discussed in scientific literature. It also explains FDA's thinking on certain types of correction and removal actions
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Regulatory News In Brief
Baxter burn treatment gains FDA go-ahead: Baxter plans to launch its Artiss fibrin sealant adhesive for attaching skin grafts onto burn patients at the American Burn Association annual meeting April 29-May 2 in Chicago after receiving biologic license application approval March 19. Artiss is the "first and only" slow-setting fibrin sealant approved for the indication, Baxter notes. Unlike rapid-setting fibrin sealant tissue adhesives, which also contain the blood-clotting proteins fibrinogen and thrombin, Artiss has a lower concentration of thrombin, FDA notes. This allows surgeons more time to position the grafts before adherence to the skin, according to the agency. Intended as an alternative to staples, Artiss also contains aprotinin, a synthetic protein that delays the breakdown of blood clots
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