(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no...
REQUIREMENTS 328 含有酒精的预期用于口部摄入的非处方药品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL 一般认为安全与有效以及不错误标识的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 用于非...
1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的...
A labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification)for a specified device or ...
美国FDA《联邦规章典集》(CFR)第21篇目录中文版 发布时间:2010-5-1113:44:12发布方:奥咨达医疗器械咨询 美国《联邦规章典集》(CFR)第21篇“食品与药品”总目 概述:美国《联邦规章典集》(CodeofFederalRegulations,CFR)第21篇“食品与药品(”Title21―FoodandDrugs)共有9卷(Volume)、 3章(Chapter)、1499部(Pa...
within 60 days after the date of the de- Subpart C—Labeling Requirements for cision involved will be denied as un- Over-the-Counter Devices timely, unless CDRH, for good cause, permits the request to be filed after 60 801.60 Principal display panel. 801.61 Statement of identity. days. An...
(CGMP) requirements are set fort in this quality system regulation.The requirementsinthis partgovernthe methodsusedin,andthefacilitiesandcontrolsusedfor,thedesign, manufacture,packaging, labeling,storage,installation,and servicing of allfinished devices intendedfor human use.The requirements in this part ...
812.5Labeling of investigational devices.标记调查用的机械 812.7Prohibition of promotion and other practices.推广的禁用和实行812.10Waivers.豁免 812.18Import and export requirements.进口和出口的需求。 812.19Address for IDE correspondence.IDE对应的定位
labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under sectio...
医疗器械标签的相关指导原则由FDA下属的器械和辐射健康中心(CDRH)负责起草,分别1989年发布的医疗器械标签管理规范(Labeling regulatory requirements for medical device)和1991年发布的医疗器械标签和说明书指导原则(Device Labeling Guidance)。 1.2指导原则概况