美国FDA 指导原则 提交放射性核素剂量校准器上市前通知的行业指南(PDF格式) 英文原版.pdfVIP

Guidance for Industry Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators Document Issued on: November 20, 1998 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Radiological Devices Branch Division of Reproductive; Abdominal; Ear, Nose, and Throat; and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Robert Phillips, Ph.D., Radiological Devices Branch, Division of Reproductive; Abdominal; Ear, Nose, and Throat; and Radiological Devices, 9200 Corporate Blvd, Rockville, MD 20874. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Robert Phillips, Ph.D., at (301) 594-1212. Additional Copies World Wide Web CDRH page at /cdrh/ode/radcalibrators.pdf or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 2238 when prompted for the document shelf number. 2 Table of Contents Section Page I. Purpose 4 II. Scope 4 III. Background