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.pdfVIP

Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) (Text Only)  SHARE  TWEET  LINKEDIN  PIN IT  MORE SHARING OPTIONS o LINKEDIN o PIN IT  EMAIL  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: Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories, and Related Measurement Devices To: ODE Review Staff Purpose. The purpose of this guidance is to promoted uniformity and efficiency in the review of submissions for Diagnostic Ultrasound Equipment, Accessories, and Related Measurement Devices. 510(k) submissions for these devices may have been reviewed in different divisions depending upon the intended use of a specific device. This guidance assures the consolidation of responsibility for review of 510(k) submissions and their supporting IDEs for these devices within one division,while at the same time maintaining inter- divisional consultations, as necessary, to assure the high level of expert review that has been applied in the past. This memorandum clarifies the roles and responsibilities of the primary reviewing division and the consulting divisions and sets forth the procedures they will use for this review process. Identification