美国FDA 指导原则 常见问题-关于第三方和医院再处理商对一次性设备的再处理和再利用--为行业、FDA工作人员、第三方和医院再处理商提供的三个额外问题指南 英文原版.pdfVIP

For questions regarding devices regulated by the Center for Devices and Radiological Health, contact the Infection Control Devices Branch (INCB) at (301) 796-5580. Contains Nonbinding Recommendations Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 2085