• Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff • Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and F...
这个新数据集是CDRH为了减轻医疗器械上市前流程的负担、提高生物相容性评估方法的一致性和透明度所做的持续努力的一部分。 在2016年,CDRH发布了首个版本的FDA生物相容性指南( FDA’s Biocompatibility Guidance ),该指南基于国际共识标准ISO 10993第1部分(ISO 10993 Part 1)。这份指南概述了CDRH如何在风险管理流程中...
Cabral Bigman
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017. The f...
Draft guidance documents are not intended for implementation purposes. Additionally, information is located on the FDA website in a section entitled "Device Advice" (Device Advice: Comprehensive Regulatory Assistance. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ . October 2014), which...
Draft guidance documents are not intended for implementation purposes. Additionally, information is located on the FDA website in a section entitled "Device Advice" (Device Advice: Comprehensive Regulatory Assistance. http:// www. fda. gov/ MedicalDevices/ DeviceRegulation andGuidance/ . October 2014...
FDA Condom Import Draft Guidance Includes Three Compliance LevelsHealth News Daily
(accessed 2013-05-08)US Food and Drug Administration. Early collaboration meetings under the FDA modernization act (FDAMA), final guidance for Industry and for CDRH staff; February 2001. Available at: http:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Guidan...