美国FDA 指导原则 唯一设备识别器系统常见问题第一卷工业和食品药品监督管理局工作人员指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Unique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff Document issued on August 20, 2014. On November 5, 2014 this document was edited to correct the Summary of Compliance Dates for UDI Implementation table on page 6 and citation on page 10. For questions for the Center for Devices and Radiological Health regarding this document contact UDI Regulatory Policy Support, 301-796-5995, email: udi@. For questions for the Center for Biologics Evaluation and Research regarding this document, contact the Office of Communication, Outreach and Development at 1-800-335-4709 or 240- 402-7800, email: ocod@ . U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research 1 Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to . Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies CDRH Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@ to receive a copy of the guidance. Please use the document number 1400050 to ide