什么是 510(k) Clearance

在医疗器械注册文件中，时不时会出现 510(k) Clearance 或者 510(k) Market Clearance 这个词。到底背后有啥内涵呢？

今天就来一探究竟吧！

先看最权威的出处，USFDA 官网解释：

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month. See the links on the left side of this page to find monthly listings of 510(k)s cleared by FDA.

《食品、药品和化妆品法案》第 510(k) 条要求需要强制注册的器械制造商至少提前 90 天通知 FDA 其医疗器械的上市意图。这就叫上市前通知 - 也称为 PMN 或 510(k)。这使 FDA 可以决定该器械是否等同于已归入三个分类类别之一的一种器械。从而可以正确识别尚未分类的“新”器械（1976 年 5 月 28 日之前未进行商业销售）。具体而言，如果医疗器械制造商打算首次对器械进行商业分销或重新引入即将进行重大改造或修改以至影响其安全性或有效性的器械，则必须提交上市前通知。此类改造或修改可能与设计、材料、化学成分、能源、制造过程或预期用途有关。

由此可知，510(k) Clearance 就是 FDA 对准备上市的医疗器械进行的核准。如果通过核准，则成为 510(k) cleared device。 故 510(k) Clearance 可译为“510(k) 上市前核准”。