Premarket Requirements

上市前要求

You must follow the steps below prior tomarketing a medical device in the United States:

在美国销售医疗器械之前，你必须按照以下步骤操作：

· Step One: ClassifyYour Device

· 步：对器械分类

· Step Two: Choose theCorrect Premarket Submission

· 第二步：选择正确的上市前提交

· Step Three: Preparethe Appropriate Information for your Premarket Submission to the FDA

· 第三步：上市前向FDA提交适当的信息

· Step Four: Send yourPremarket Submission to the FDA and Interact with FDA Staff during Review

· 第四步：将上市前提交发送给FDA，并在审核期间与FDA员工沟通

· Step Five: Completethe Establishment Registration and Device Listing

· 第五步：完成企业注册和器械列表

Step One:Classify Your Device

步：对器械分类

The first step in preparing a device for marketingis to find the federal regulation that classifies your device. A medical deviceis defined by law in the section 201(h) of the FD&C Act, and theclassification, which may be found in the Code of Federal Regulations,determines the regulatory path and regulatory requirements for your device.

器械销售的步是找到相关的分类法规。医疗器械由FD&C法案第201（h）的法律规定，分类可在联邦法规中找到，确定器械的监管路径和法规要求。

While the FDA will officially classify yourmedical device when reviewing your premarket submission, it is helpful for youto identify the classification. This will allow you to select the correctregulatory submission path and become aware of the level of regulatory controlthat is necessary to assure the safety and effectiveness of the medical device.

当FDA查看你的上市前提交，将正式分类你的医疗器械，这也有助于你识别分类。这将允许您选择正确的监管提交路径，并了解确保医疗器械的性和有效性所必需的监管控制水平。

Medical devices are categorized into one ofthree classes, based on the degree of risk they present. These classes are asfollows:

医疗器械根据其存在的危险程序分为三类中的一类。这些分类如下：

· Class I – Lowest Risk

· I类—低风险

An example of a Class I device is a manual toothbrush. Class I devicesare subject to general controls.

· I类器械的示例是手动牙刷。I类器械受一般控制。

· Class II – Moderate Risk

· II类—中度风险

Examples of Class II devices are male condoms and non-invasive bloodpressure monitors. Class II devices are subject to general controls andspecial controls.

· II类器械的示例是男性避孕套和非植入式血压检测器。II类器械受一般控制和特殊控制。

· Class III – Highest Risk

· III类—高风险

An example of Class III device is a heart valve. Class III devices aresubject to general controls andpremarket approval.

· III类器械的示例是瓣膜。III类器械受一般控制和上市前批准。

To find the classification regulation ofyour device, see:

要查找器械的分类规则，请参阅：

· FDA ProductClassification Database

· FDA产品分类数据库

· DeviceClassification Panels

· 器械分类面板

· Classify YourMedical Device

· 分类你的医疗器械

Notes:

注意：

· For help determining whether a product is a medical device,refer to Device .

· 确定产品是否为医疗器械，请参阅器械。

· If your product is a combination product - a medical device plus anotherFDA-regulated product (e.g. drug, biologics, etc.), you should contactFDA’s Office ofCombination Product (OCP) by e-mail at:combination@fda.gov. Based on yourproduct’s primary mode of action, OCP will tell you which FDA Center that youneed to contact in order to market your product.

· 如果你的产品是组合产品-医疗器械和另一个FDA管制的产品（例如，生物制剂等），你应通过电子邮件联系FDA组合产品办公室（OCP）：combination@fda.gov。根据你产品的主要作用模式，OCP将告诉你需要联系哪个FDA中心，以便销售你的产品。

· Even if your medical device does not require a premarketsubmission, it is your responsibility to make sure you have the correctclassification for your device.

· 即使您的医疗器械不需要上市前提交，您有责任确保您的器械具有正确的分类。

Step Two:Select the Correct Premarket Submission

第二步：选择正确的上市前提交

After the device classification, you thenselect the premarket submission required for that regulation. The most commontypes of premarket submissions include:

在器械分类之后，选择该规定所需的上市前提交。常见的上市前提交类型包括：

· 510(k) (Premarket Notification)

· 510（k）（上市前通知）

· PMA (Premarket Approval)

· PMA（上市前批准）

· De Novo (Evaluation of Automatic Class III Designation)

· &