**4. 异常情况报告:**注册食品设施还要求参与FDA的食品安全报告系统,如食品设备报告(FERN)和食品防御计划(Food Defense Plan)。 ### 重要性: - **保护公共健康:**注册帮助FDA监控食品供应链,确保提供给美国消费者的食品是安全、无害的。 - **合规性:**注册是向美国进口或出售食品的法律要求。未注册的设施...
The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provid...
Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries...
Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its “Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices” in 2005. Over the past 17 years, significant advancements have disrupted the market, including ...
The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term.Previous article in issue Next article in issue In 1986, the Food and Drug Administration (FDA) approved the first nucleic acid test, ...
Mao Ning: Defense cooperation between any countries should be conducive to regional peace and stability. We oppose cobbling together exclusive groupings and stoking bloc confrontation in the region. 乌通社记者:俄罗斯外长拉夫罗夫正在访...