Premarket Requirements

上市前要求

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

在美國銷售醫(yī)療器械之前，你必須按照以下步驟操作：

· Step One:?ClassifyYour Device

· 步：對(duì)器械分類

· Step Two:?Choose theCorrect Premarket Submission

· 第二步：選擇正確的上市前提交

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

· 第三步：上市前向FDA提交適當(dāng)?shù)男畔?/p>

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

· 第四步：將上市前提交發(fā)送給FDA，并在審核期間與FDA員工溝通

· Step Five:?Completethe Establishment Registration and Device Listing

· 第五步：完成企業(yè)注冊和器械列表

Step One:Classify Your Device

步：對(duì)器械分類

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.

器械銷售的步是找到相關(guān)的分類法規(guī)。醫(yī)療器械由FD&C法案第201（h）的法律規(guī)定，分類可在聯(lián)邦法規(guī)中找到，確定器械的監(jiān)管路徑和法規(guī)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.

當(dāng)FDA查看你的上市前提交，將正式分類你的醫(yī)療器械，這也有助于你識(shí)別分類。這將允許您選擇正確的監(jiān)管提交路徑，并了解確保醫(yī)療器械的性和有效性所必需的監(jiān)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:

醫(yī)療器械根據(jù)其存在的危險(xiǎn)程序分為三類中的一類。這些分類如下：

· Class I – Lowest Risk

· I類—低風(fēng)險(xiǎn)

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

· I類器械的示例是手動(dòng)牙刷。I類器械受一般控制。

· Class II – Moderate Risk

· II類—中度風(fēng)險(xiǎn)

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

· II類器械的示例是男性避孕套和非植入式血壓檢測器。II類器械受一般控制和特殊控制。

· Class III – Highest Risk

· III類—高風(fēng)險(xiǎn)

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

· III類器械的示例是瓣膜。III類器械受一般控制和上市前批準(zhǔn)。

To find the classification regulation ofyour device, see:

要查找器械的分類規(guī)則，請(qǐng)參閱：

· FDA ProductClassification Database

· FDA產(chǎn)品分類數(shù)據(jù)庫

· DeviceClassification Panels

· 器械分類面板

· Classify YourMedical Device

· 分類你的醫(yī)療器械

Notes:

注意：

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

· 確定產(chǎn)品是否為醫(yī)療器械，請(qǐng)參閱器械。

· 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.

· 如果你的產(chǎn)品是組合產(chǎn)品-醫(yī)療器械和另一個(gè)FDA管制的產(chǎn)品（例如，生物制劑等），你應(yīng)通過電子郵件聯(lián)系FDA組合產(chǎn)品辦公室（OCP）：combination@fda.gov。根據(jù)你產(chǎn)品的主要作用模式，OCP將告訴你需要聯(lián)系哪個(gè)FDA中心，以便銷售你的產(chǎn)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.

· 即使您的醫(yī)療器械不需要上市前提交，您有責(zé)任確保您的器械具有正確的分類。

Step Two:Select the Correct Premarket Submission

第二步：選擇正確的上市前提交

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

在器械分類之后，選擇該規(guī)定所需的上市前提交。常見的上市前提交類型包括：

· 510(k) (Premarket Notification)

· 510（k）（上市前通知）

· PMA (Premarket Approval)

· PMA（上市前批準(zhǔn)）

· De Novo (Evaluation of Automatic Class III Designation)

· &