美国FDA 法规 医疗器械提交指南拷贝程序 Guidance-eCopy Program for Medical Device Submissions.pdfVIP

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美国FDA 法规 医疗器械提交指南拷贝程序 Guidance-eCopy Program for Medical Device Submissions.pdf

eCopy Program for Medical Device Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on: October 10, 2013 This document supersedes the guidance of the same title dated December 31, 2012. For questions regarding this document, contact CDRH’s eCopy Program Coordinators at 240- 402-3717 or cdrh-eCopyinfo@ or CBER’s Office of Communication, Outreach and Development, at 1-800-835-4709 or 301-827-1800. U.S. Departmen

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