(Photo credit: Wikipedia) In response to increasing numbers of deaths, injuries, and addiction stemming from prescription painkiller [...]Robert Glatter
National Medical Products Administration,Beijing 100022, China Abstract: The FDA issued the Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry (Draft) in July 201...
Table of Contents INTRODUCTION BACKGROUND ABBREVIATED 510(K) SUBMISSIONS SCOPE RISKS TO HEALTH DEVICE DESCRIPTION PERFORMANCE CHARACTERISTICS LABELING Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays ?1. ...
CONCLUSION 21 ATTACHMENT: STATUTORY AND REGULATORY REQUIREMENTS FOR LABELING AND ADVERTISING 22 Contains Nonbinding Recommendations Draft — Not for Implementation 1 Guidance for Industry 2 Presenting Risk Information in Prescription Drug and Medical 3 Device Promotion 4 5 6 7 This draft guidance, when...
3. Medical Device Safety: The FDA oversees the safety and performance of medical devices, such as pacemakers, implants, and diagnostic equipment. They evaluate the design, manufacturing, and labeling of these devices to ensure they meet safety standards and are effective in their intended use. 4...
Administration (FDA) today issued draft guidelines that would permit drug and device makers to provide information on off-label uses, but only if the request for information is unsolicited. An unsolicited request is one not initiated in any form by the drug or device maker or distributor itself...
Special labeling requirements 特殊标签要求 Premarket data requirements 上市前数据要求 Guidelines 指导文件 上市前审批(PMA) 所有的III类器械都需要PMA申报。FDA规定那些维持生命、用来阻止损害健康、或者存在潜在致病风险的器械都需要进行PMA申报。而且如果无法通过一般管控和特殊管控获得足够的安全性和有效性证明的器械,也...
(SUBCHAPTER—:00D FOR HUMAN CONSUMPTION ) 总则 GENERAL 食品标识 FOOD LABELING 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE 婴儿配方母乳替代食品质量控制程序...
FDA常用指南文件清单 序号中文文件名称原文文件名称1上市前批准申请模块审核Premarket Approval Application Modular Review2医疗器械的电子副本提交程序eCopy Program for Medical Device Submissions3上市前批准…
801 标识LABELING 803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方...