美国FDA 指导原则 拉莫三嗪和唑尼沙胺检测上市前通知的建议工业和食品药物管理局工作人员指南 英文原版.pdfVIP

Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays Guidance for Industry and Food and Drug Administration Staff Document issued on: February 9, 2016 The draft of this document was issued on August 6, 2010 For questions about this document, contact Division of Chemistry and Toxicology Devices at 301-796-6933. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health Division of Chemistry and Toxicology Devices 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. Identify all comments with the docket number [FDA- 2010-D-0395]. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies 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 1654 to identify the guidance you are requesting. 2 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 4 II. BACKGROUND - LAMOTRIGINE AND ZONISAMIDE ASSAYS 5 III. SCOPE 5 IV. DEVICE DESCRIPTION 6 V. PERFORM