美国FDA 指导原则 使用真实世界证据支持医疗器械监管决策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 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 31, 2017. The draft of this document was issued on July 27, 2016 For questions about this document regarding CDRH-regulated devices, contact the Office of Surveillance and Biometrics (OSB) at 301-796-5997 or CDRHClinicalEvidence@. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010. 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 Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2016-D-2153. 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 1500012 to identify the guidance you are requesting. CBER Additional copies are available from the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach, and De