3) medical devices 医疗器械 4) radiation-emitting products 辐射产品 5) vaccines，blood and biologics 疫苗，血液和生物制品 6) animal and veterinary 动物 7) cosmetics 化妆品 8) tobacco products烟草 医疗器械分类 生产、包装已经进口医疗设备的企业，受FDA的设备及放射卫生中心CDRH的管制。
Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on responsibility for consumer protection against unnecessary exposure to radiation-emitti...
Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use, a function that formerly had b...
所以普通LED灯进口美国市场不需要递交FDA产品报告和年报,也不需要执行FDA认证性能标准。目前在FDA radiation-emitting electronic products发射辐射电子产品强制管控的产品有:Laser激光, X-ray射线,Microwe微波类产品,这些产品有具体的FDA 认证性能标准,必须递交FDA 产品报告和年度报告。 ※ FDA-2877 form是什么? 美国FDA...
作为一个科学管理机构,FDA的职责是确保美国本国生产或进口的食品(food)/化妆品(cosmetics)/药物(medications)/生物制剂(biopharmaceuticals)/医疗器械(medical devices)和放射性产品(electromagnetic radiation emitting devices)对人体的安全。它是最早以保护消费者为主要职能的联邦机构之一。
右侧上方PRODUCTS选项下包括八种类型产品,分别是Food(食品)、Drugs(药品)、Medical Devices(医疗器械)、Radiation-Emitting Products(放射性产品)、Vaccines, Blood, and Biologics(疫苗、血液和生物制品)、Animal and Veterinary(动物和兽医制品)、Cosmetics(化妆品)、Tobacco Products(烟草)。点击任意一项即可快速进入该产...
右侧上方PRODUCTS选项下包括八种类型产品,分别是Food(食品)、Drugs(药品)、Medical Devices(医疗器械)、Radiation-Emitting Products(放射性产品)、Vaccines, Blood, and Biologics(疫苗、血液和生物制品)、Animal and Veterinary(动物和兽医制品)、Cosmetics(化妆品)、Tobacco Products(烟草)...
作为一个科学管理机构,FDA的职责是确保美国本国生产或进口的食品(food)、化妆品(cosmetics)、药物(medications)、生物制剂(biopharmaceuticals)、医疗器械(medical devices)和放射性产品(electromagnetic radiation emitting devices)对人体的安全。它是最早以保护消费者为主要职能的联邦机构之一。
Radiation-Emitting Products Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to submit ...
受美国FDA的管制的消费类产品(不属消费品安全委员会管制) Food食品 Direct food additives直接食品添加物 Indirect food additives非直接食品添加物 Drugs药物 Medical Devices医疗设备 Cosmetics化妆用品 Radiation-Emitting Products辐射散发产品 Biologics生物制品