Section 510(k) of the Food, Drug an

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.

結果 (繁體中文) 1:

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.

CDRH的列表基本上等價的510（k）類為通常可得到大約每個月的第五對前一個月。請參閱本頁面左側的鏈接找到的510（k）的每月清單■通過FDA批准。

結果 (繁體中文) 2:

《食品、藥品和化妝品法》第 510（k） 節要求必須註冊的設備製造商至少提前 90 天通知 FDA 他們打算銷售醫療器械。這稱為上市前通知 - 也稱為 PMN 或 510（k）。這允許 FDA 確定該設備是否等同于已放入三個分類類別之一的設備。因此，可以正確識別尚未分類的"新"設備（1976 年 5 月 28 日之前未進行商業分發）。具體來說，如果醫療器械製造商打算首次將設備引入商業分銷，或重新引入將顯著更改或修改到以下程度的設備，則需要提交上市前通知其安全性或有效性可能會受到影響。此類更改或修改可能與設計、材料、化學成分、能源、製造過程或預期用途有關。

CDRH 大致等價 510（k）s 的清單通常每月 5 點左右在上個月提供。請參閱此頁面左側的連結，查找 FDA 批准的 510（k）s 的每月清單。

結果 (繁體中文) 3:

《食品、藥品和化妝品法》第510（k）節要求必須注册的器械製造商至少提前90天將其銷售醫療器械的意圖通知fda。這被稱為售前通知-也稱為PMN或510（K）。這使得fda能够確定該設備是否等同於已經被歸入三個分類類別之一的設備。囙此，可正確識別未分類的“新”裝置（1976年5月28日之前不在商業分銷中）。具體而言，如果醫療器械製造商打算首次將器械引入商業分銷，或重新引入一種將在可能影響其安全性或有效性的情况下進行重大改變或修改的器械，則需要提交一份上市前通知。這種變化或修改可能與設計、資料、化學成分、能源、制造技術或預期用途有關。
基本上相當於510（k）s的cdrh清單通常在上個月的每月5日左右提供。請參閱本頁左側的連結，以查找FDA準予的510（k）s的月度清單。