FDA常见术语中英对照版（持续更新中）

Premarket Notification 510(k)

上市前通知510(k)

De Novo Classification Request

新分类申请

Premarket Submission Number

上市前申报编号

Intended Use

预期用途

Predicate Device

对比器械

Multiple Predicate Devices

多个对比器械

Reference Device

参考器械

Performance Data

性能数据

510(k) Summary

510(k) 摘要

510(k) Statement

510(k) 声明

510(k) Third Party Review Program

510(k) 第三方审查计划

General Controls

一般管制要求

Special Controls

特殊管制要求

Least Burdensome Approach

最少负担原则

Trade Name

商品名称

Preamendment Device

修正案前医疗器械

Postamendment Device

修正案后医疗器械

Medical Device Amendment

FDA医疗器械修正案

New Device

新型医疗器械

PMA Amendment

PMA修正案

PMA Supplement

PMA补充申请

FDA Guidance

FDA指南文件

Unclassified Device

未分类医疗器械

Interactive Review

交互式评审

FDA Cleared

FDA上市许可