美国兽医器械监管体系分析及启示OA

In order to comprehensively understand the framework and functioning of the regulatory system for veterinary devices in the United States,the legal framework,classification,institutional structure,and operational mechanism of the system were systematically reviewed.The results showed that veterinary devices in the United States were governed by the Federal Food,Drug,and Cosmetic Act,under which they were incorporated into the common regulatory framework for medical devices and managed through a risk-based classification system.An end-to-end regulatory mechanism was established,covering premarket notification,premarket approval,quality system regulation,adverse event monitoring,and product recall.In addition to safeguarding the safety and effectiveness of veterinary devices,the system accommodated both animal health protection and industrial innovation.Its regulatory approach,characterized by risk-based classification and end-to-end control,provided references for relevant legislation and regulatory practices in China.