美国FDA 指导原则 工业指南和FDA审查员指南关于1997年食品和药物管理局现代化法案第216条的指南(PDF格式) 英文原版.pdfVIP

Guidance for Industry and for FDA Reviewers Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 Document issued on August 9, 2000 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Preface Public Comme