Medical DevicesFDA Medical Devices Application

U.S. FDA Medical Device 510(k)

美国《食品、药品和化妆品法案》第 510(k) 条要求必须注册的设备制造商至少提前 90 天通知 FDA 其销售医疗设备的意图。这称为上市前通知 – 也称为 PMN 或 510(k)。这允许 FDA 确定该设备是否等同于已归入三个分类类别之一的设备。因此，可以正确识别尚未分类的“新”设备（在 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将器械引入商业分销或重新引入将对其安全性或有效性进行重大改变或修改的器械，则要求医疗器械制造商提交上市前通知。此类更改或修改可能与设计、材料、化学成分、能源、制造过程或预期用途有关。

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Medical DevicesObtain U.S. Marketing Authorization

Any medical device intended for sale in the United States must obtain marketing authorization

Any Class I, II, or III medical device intended for sale in the U.S. must submit a 510(k) to the FDA, unless the device qualifies for a 510(k) exemption under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements for 510(k) submissions are outlined in 21 CFR 807 E. Prior to marketing the device, the submitter must receive a letter from the FDA confirming that the device is substantially equivalent (SE) to a legally marketed device of the same type that has already been cleared for sale in the U.S.

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Data Organization and AnalysisTesting Data Required for Medical Device Applications

中沃德康协同全球合作伙伴提供具有包括ISO, GLP,FDA规范的技术文件，用以提交医疗器械申请所需的测试数据，并利用已知数据为监管机构架构完整的数据链，让医疗器械数据清晰，可控提交与监管机构

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Medical DevicesMedical Device Substantial Equivalence

Medical Device 510(k) Substantial Equivalence Documentation Submission

A 510(k) is a premarket submission to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device, meaning it is substantially equivalent (per FD&C Act Section 513(i)(1)(A)). The submitter must compare their device with one or more similar legally marketed devices and provide evidence to support their substantial equivalence claim.

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