美国FDA 指导原则 设备软件功能上市前提交的内容工业和食品药品监督管理局工作人员指南草案 英文原版.pdfVIP

Contains Nonbinding Recommendations Draft – Not for Implementation Content of Premarket Submissions for Device Software Functions ______________________________________________________________________________ Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This draft guidance document is being distributed for comment purposes only. Document issued on November 4, 2021. You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments 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 listed in the notice of availability that publishes in the Federal Register . For questions about this document regarding CDRH-regulated devices, contact the Digital Health Center of Excellence at digitalhealth@. 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, or by email at ocod@. When final, this guidance will supersede Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Reco