超声诊断设备、附件及相关测量设备#G90-2提交资料的综合评审英文原版.pdf

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Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) (Text Only)

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 PRINT This guidancewas written priorto the February 27, 1997 implementationof FDA’s Good Guidance Practices,GGP’s. It does not create or confer rightsfor oronany personand does not operate to bind FDA orthe public.An alternative approach may be used if suchapproachsatisfies the requirements of the applicable statute, regulations,or both.This guidancewill be updated in the next revisionto include the standard elements of GGP’s. General Program Memorandum#G90-2 Date: Oct. 19, 1990 From : Director, Office of Device Evaluation (HFZ-400) Subject: Consolidate

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