美国FDA 指导原则 提交上市前通知的用户费用和退款(510(K)s)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 User Fees and Refunds for Premarket Notification Submissions (510(k)s) Guidance for Industry and Food and Drug Administration Staff Document issued on October 5, 2022. Document originally issued on May 28, 2004. This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” issued on October 2, 2017. For questions regarding submissions to the Center for Devices and Radiological Health (CDRH), contact the Office of Regulatory Programs / Division of Submission Support / 510(k), De Novo, 513(g), Device Determinations and Custom Devices Lifecycle Team at 301-796-5640, or by email at OPEQSubmissionSupport@. For questions regarding submissions to the Center for Biologics Evaluation and Research (CBER), contact the Office of Communication, Outreach, and Development (OCOD) at 1-800- 835-4709 or 240-402-8010, or by email at ocod@. U.S. Department of Health and Human Services 1 Food and Drug Administration . FOOD DRU G ADIMINIS i RATION Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit written 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- 1740. Identify all comments with the docket number FDA-2003-D-0198. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies CDRH Additional copies are