Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule [0.03%]
婴儿配方食品现行的良好生产规范、质量控制程序、质量因素、申报要求以及记录和报告的最终规定
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notificatio...
Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule [0.03%]
食品药品监督管理局安全与创新法案中的合格病原体清单建立。最终规则
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of "qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generat...
Final priority; National Institute on Disability and Rehabilitation Research--Rehabilitation Engineering Research Centers. Final priority [0.03%]
最终优先事项；残疾和康复管理局---康复工程研究中心最终优先项目
Office of Special Education and Rehabilitative Services, Department of Education
Office of Special Education and Rehabilitative Services
The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitati...
Medical devices; general and plastic surgery devices; classification of the powered surgical instrument for improvement in the appearance of cellulite. Final order [0.03%]
医疗器械；一般和整形外科器械；用于改善橙皮病外观的电动手术器械分类最终命令
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). The Agency is classifying the device into class II (special controls) in ...
General and plastic surgery devices: reclassification of ultraviolet lamps for tanning, henceforth to be known as sunlamp products and ultraviolet lamps intended for use in sunlamp products. Final order [0.03%]
通用和整形外科设备：将晒黑用紫外线灯重新分类为“人造日光浴产品”以及用于此类产品的紫外线灯。最终命令
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket...
Microbiology devices; reclassification of nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens. Final rule [0.03%]
结核分枝杆菌核酸检测仪重新分类为Ⅲ类医疗器械最终规则
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (speci...
Medical devices; immunology and microbiology devices; classification of dengue virus serological reagents. Final order [0.03%]
医疗器械；免疫及微生物学器械——登革热病毒血清学试剂的分类 最终命令
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the den...
Medical devices; gastroenterology-urology devices; classification of pancreatic drainage stent and delivery system. Final order [0.03%]
医疗器械；胃肠病和泌尿科设备；胰导管引流支架和输送系统的分类。最终命令
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of t...
Administrative detention of drugs intended for human or animal use. Final rule [0.03%]
关于拟用于人类或动物的管制物质行政拘留的最终规定
Food and Drug Administration, HHS
Food and Drug Administration
The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the...
Patient Protection and Affordable Care Act; exchange and insurance market standards for 2015 and beyond. Final rule [0.03%]
患者保护与平价医疗护理法；2015年及以后的交易所和保险市场标准。最终规则
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS)
Centers for Medicare & Medicaid Services (CMS)
This final rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affor...