food drug cosm.l.jGostin, L. O. (2008). The deregulatory effects of preempting tort litigation: FDA regulation of medical devices. JAMA, 299, 2313-2316.Robert Higgs, "FDA Regulation of Medical Devices," in Higgs, Ed., Hazardous to Our Health?, pp. 55- 95....
FDA Regulations for Medical Devices: 21 CFR Title 21 of the Code of Federal Regulations, also known as 21 CFR, is a critical regulation for medical devices. It sets the requirements for FDA approval of medical devices. Electronic Records (21 CFR Part 11) 21 CFR Part 11 regulates the use...
随着科学知识的进步,该机构不断发展其法律,以确保以最有效的方式监管这些产品。 从2002年开始,CDRH开始实施医疗器械使用费计划,受监管的设备行业向CDRH提供使用费,目的是推进监管决策。有关FDA对医疗器械监管历史的更多信息,请参考http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ucm618375.htm...
(https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device) 最后是关键资源端口。 1. e-CFR 好用的Code of Federal Regulation的阅读网站。 https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee...
(https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device) 最后是关键资源端口。 1. e-CFR 好用的Code of Federal Regulation的阅读网站。 https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ec...
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载。 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 二、医疗器械FDA验厂 美国FDA注册,FDA510K,FDA验厂,针对美国市场,其中FDA注册是强制性要求,普通FDA注册和产品列名是...
(FDA) regulates mobile medical apps to protect patients and ensure the apps meet high standards of safety, effectiveness and security. When medical devices have a mobile app, the FDA considers the cybersecurity posture of the mobile app as an important part of the medical device review and ...
provisionsofthisregulationasguidance.Manufacturersofhumanbloodandblood componentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter. Manufacturersofhumancells,tissues,andcellularandtissue-basedproducts(HCT/Ps),as definedin1271..3(d)ofthischapter,thataremedicaldevices(subjecttopremarketreviewor notificatio...
Medical Devices and the FDA Approval Process: Balancing Safety and Innovation The use of medical devices has greatly increased during the past decade. Indeed, more than 8000 new medical devices are marketed in the United States annua... None - 《Archives of Internal Medicine》 被引量: 36发表:...
U.S. FDA Medical Device Regulation: 21 C.F.R. Part 801 et seq. UDI-GUDID Regulations: 78 Fed. Reg. 58785, 58785-58828 U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9. U.S. FDA MAF Regulation: 21 C.F.R. section 814.9. ...