Medical devices post-approval studies program: vision, strategies, challenges and opportunities.

作者信息

Marinac-Dabic Danica, Bonhomme Michele, Loyo-Berrios Nilsa, Gross Thomas, Ciperson Robert, Gardner Susan, Marcarelli Michael

机构信息

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.

出版信息

Food Drug Law J. 2007;62(3):597-604.

PMID:17915402

Abstract

摘要

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