美国FDA 法规 指南-呼吸机评审指南草案Guidance-Draft Reviewer Guidance for Ventilators.pdfVIP

This guidance was written prior to the February 27, 1997 implementation of FDAs Good Guidance Practices, GGPs. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance willbe up dated in the next revision to include the standard elemnts of GGPs . WORKINGDRAFT - FOR COMMENT DRAFT REVIEWER GUIDANCE FOR VENTILATORS July 1995 Anesthesiology, Respir