近日,FDA发布了一份联邦公报《Food and Drug Administration Modernization Act of 1997:Modifications to the List of Recognized Standards,Recognition List Number:061》,该文件用于修改或更新上市前审查的医疗器械标准列表(FDA认可的共识标准,帮助选择符合共识标准声明的制造商,以满足医疗器械的特定要求。 这些FDA认可的...
●近期FDA发布了“Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061”联邦公告文件。 该文件用于修改或更新上市前审查的标准列表(FDA认可的共识标准,将帮助选择符合共识标准声明的制造商,以满足医疗器械的特定要求。 这些对公认...
下面是我从官网上下载的文件截图，网址：https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStan...
The article reports that the ISA/IEC 62443 series of industrial automation and control systems (IACS) security standards of the International Society of Automation (ISA) was included by the U.S....
美国FDA分析方法验证指南中英文对照四美国FDA分析方法验证I. INTRODUCTIONThis guidance provides recommendations to applicants on submitting analytic
If the analytical procedure used is in the current revision of the USP/NF or other FDA recognized standard references (e.g., AOAC International Book Of Methods) and the referenced analytical procedure is not modified, a statement indicating the analytical procedure and reference may be provided ...
FDA-Recognized Standards on Human Factors FDA认可的人因相关的标准 FDA已经官方认可了国家和国际标准组织发布的器械专标和通标。FDA认可的人因相关的标准如下表所示: FDA-Guidance Documents Related to Human Factors 与人因相关的FDA指南文件 FDA已经有几份指南文件,用以帮助生厂商在设计产品时应用适当的人因方法...
7. Recognized Standards The following is a list of FDA recognized consensus standards dealing with Information Technology (IT) and medical device security. 6 Contains Nonbinding Recommendations 1. CLSI, AUTO11-A - IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard...
1.Howmany standards has FDA recognized? Where can the current list of recognizedstandards be found? FDA认可了多少标准?目前公认的标准清单在哪里可以找到? FDA has recognized approximately 400standards to which 510(k) submitters can declare conformity. The list of thesestandards can be found at on ...
For additional information or questions about the FDA-recognized standards referenced in this guidance document, please contact CDRH’s Standards Program.1 有关本指南文件中引用的FDA认可标准的其他信息或疑问,请联系CDRH的标准计划。 1 Web site addresses for all hyperlinked material in this guidance docume...