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【技术产业】Shelhigh与FDA就心脏手术用植入式医疗
05 Jul 2007
Shelhigh announced today that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to the resumption of operations at Shelhigh, including product shipment.
"I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving products to patients around the world," said Dr. Shlomo Gabbay, Chief Scientific Officer for Shelhigh.
The FDA acknowledges that it did not mandate a product recall, Shelhigh did not conduct a recall, and no product recall is required by the settlement just announced.
The agreement calls for independent experts to inspect and certify that Shelhigh's manufacturing processes are in substantial compliance with Federal regulations. These independent inspectors have already begun their review and the firm anticipates that any required changes will be easily implemented. Upon completion of the experts' certification, the FDA will conduct normal inspections to confirm that the requested changes were made. Importantly, this approach will provide the fastest means for Shelhigh to resume product shipment.
This was not an agreement ordered by the court, but rather a mutual no-fault settlement that the court agreed to sign so that FDA and Shelhigh can resume good relations, and Shelhigh can resume delivering its life-saving products. Shelhigh is pleased to announce that FDA declared, "FDA did not invoke the Federal Food, Drug, and Cosmetic Act to mandate that Shelhigh recall its devices, and Shelhigh did not conduct a recall of its devices."
"Shelhigh has always been committed to maintaining a good working relationship with the FDA, while providing its life-saving products to patients in need," said Dr. Gabbay. "As is well-documented, Shelhigh's track record of providing effective and revolutionary products is extraordinary, and we are pleased to demonstrate that our manufacturing process is exact and complete, and in full compliance."
About Shelhigh
Shelhigh is known for its proprietary No-React(R) tissue products that utilize the widely accepted glutaraldehyde fixation process while avoiding the acknowledged problems that accompany glutaraldehyde. No-React tissue products have over 10 years proven performance of resisting infection and calcification, even in cases of active infective endocarditis. Today Shelhigh offers a wide variety of cardiothoracic surgical solutions, all incorporating No-React tissue for superior performance. To learn more about Shelhigh and its products please visit http://www.shelhigh.com. Visitors may also sign up for the Shelhigh newsletter for automatic updates.
http://www.shelhigh.com
Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=76065 本人已认领该文编译，如48小时未能提交译文，请其他战友自由认领
Shelhigh And FDA Reach An Agreement - Implantable Medical Devices, Used In Heart Surgery
05 Jul 2007
Shelhigh与FDA就心脏手术用植入式医疗器械达成协议
Shelhigh announced today that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to the resumption of operations at Shelhigh, including product shipment.
Shelhigh公司今日宣布，该公司与美国FDA达成一项无过错协议，为Shelhigh公司恢复生产、产品出货
"I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving products to patients around the world," said Dr. Shlomo Gabbay, Chief Scientific Officer for Shelhigh.
“我非常高兴地看到FDA与Shelhigh能够达成协议，允许我们的救命产品恢复全球供货。” Shelhigh公司CSO Shlomo Gabbay博士说道。
The FDA acknowledges that it did not mandate a product recall, Shelhigh did not conduct a recall, and no product recall is required by the settlement just announced.
FDA承认，FDA没有要求产品召回，Shelhigh也没有召回其产品，而刚刚宣布的协议也不要求产品召回。、
The agreement calls for independent experts to inspect and certify that Shelhigh's manufacturing processes are in substantial compliance with Federal regulations. These independent inspectors have already begun their review and the firm anticipates that any required changes will be easily implemented. Upon completion of the experts' certification, the FDA will conduct normal inspections to confirm that the requested changes were made. Importantly, this approach will provide the fastest means for Shelhigh to resume product shipment.
协议要求独立专家核查并证实Shelhigh公司的生产过程实际上遵守有关联邦法规。这些独立检查员已经开始调查，公司预期任何一项必需的改进将易于实现。在专家认证完成之前，FDA将执行正常的检查程序以证实该公司进行了必需的改进。对于Shelhigh公司来说，重要的是该处理方式是其恢复产品出货的最快办法。
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作者:admin@医学,生命科学 2011-02-17 05:11
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