关键词: 医疗器械, 美容用器械, 管理属性, 管理类别, 风险管控

Abstract:

Objective： To explore the regulatory philosophy and characteristics of the US Food and Drug Administration （FDA） regarding aesthetic devices， provide references for the regulation of similar products in China， and facilitate the high-quality development of the industry.Methods： By searching FDA Total Product Life Cycle （TPLC） database， product classification database， PMA database， 510（k） database， and De Novo databases， to review the classification of medical aesthetic devices ， the corresponding market approval pathways， the number of adverse events， and risk control measures in the production and use phase， and to summarize FDA's classification management policies and regulatory requirements for aesthetic devices， so ao to provide reference for China's scientific regulation. Results and Conclusions： FDA's definition of medical devices includes aesthetic devices. Through classification regulations， special control guidelines， official website documents， and other regulatory documents， it clarifies classifications and specific regulatory requirements of aesthetic devices. Based on product risks， targeted regulatory measures have been formulated for both the production and use phases， with particular emphasis on the use phase， and a series of information required for the safe use of aesthetic devices have been provided. FDA emphasizes full-chain management of aesthetic devices to ensure safety throughout the product life-cycle， as well as multi-departmental coordination. The above regulatory practices provide valuable reference for the regulation of aesthetic devices in China.

Key words: Medical devices； , Aesthetic devices； , Regulatory attributes； , Regulatory classification； , Risk management