美国FDA 指导原则 实验室开发试验监管框架(LDTS)工业、食品和药品监督管理局工作人员和临床实验室指南草案 英文原版.pdfVIP

Contains Nonbinding Recommendations Draft - Not for Implementation 1 2 Draft Guidance for Industry, Food and 3 Drug Administration Staff, and Clinical 4 Laboratories 5 6 7 Framework for Regulatory Oversight of 8 Laboratory Developed Tests (LDTs) 9 10 DRAFT GUIDANCE 11 12 13 This guidance document is being distributed for comment purposes only. 14 Document issued on: tber , 2014 15 16 You should submit comments and suggestions regarding this draft document within 120 days 17 of publication in the Federal Register of the notice announcing the availability of the draft 18 guidance. Submit written comments to the Division of Dockets Management (HFA-305), 19 Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit 20 electronic comments to . Identify all comments with the docket 21 number listed in the notice of availability that publishes in the Federal Register . 22 23 For questions regarding this document, contact LDTframework@. For questions 24 regarding this document as applied to devices regulated by CBER, contact the Office of 25 Communication, Outreach and Development in CBER at 1-800-835-4709 or 240-402-7800 or 26 ocod@. 27 28 29 30 U.S. Department of Health and Human Services 31 Food and Drug Administration 32 Center for Devices and Radiological Health 33 O