美国FDA 指导原则 选择某些与完整皮肤接触的设备的生物兼容性更新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Contains Nonbinding Recommendations Draft – Not for Implementation Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This draft guidance document is being distributed for comment purposes only.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 October 15, 2020. You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 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, contact the Office of Product Quality and Evaluation (OPEQ)/Clinical and Scientific Policy Staff at CDRH.Biocomp@ or (301)-796-5701. When final, this guidance will update Sections II and III and add a new Attachment to “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,’” issued on June 16, 2016. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Contains Nonbinding Recommendations Draft – Not for Implementation Preface Additional Copies Add