介绍
Medical devices marketed in the UnitedStates are subject to the regulatory controls in the FederalFood, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts1-58, 800-1299.
在美国销售的医疗器械受联邦食品，药品和化妆品法案（FD&C Act）和联邦法规第21章-（21 CFR）第1至58部分，800-1299条控制。
Medical devices that emit radiation are alsosubject to regulations for radiation-emittingelectronic products cited in 21CFR Parts 1000-1050.
放射辐射的医疗器械也受21CFR1000-1050中放射辐射的电子产品的规定约束。
Some requirements apply to medical devicesbefore they are marketed (premarket requirements), and other apply to medicaldevices after they are marketed (postmarket requirements).
一些要求适用于医疗器械上市前（上市前要求），其他要求适用于医疗器械上市后（上市后要求）。
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
· 第一步：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
第一步：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.
器械销售的第一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安全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类器械的示例是心脏瓣膜。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
· 器械分类面板
· 分类你的医疗器械
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（例如药物，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。
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。最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)
· De Novo（自动化III类指定评估）
· HDE (Humanitarian Device Exemption)
· HDE（人道主义豁免器械）
Some Class I and most Class II devicesrequire a 510(k). In a 510(k), the sponsor must demonstrate that the new deviceis “substantially equivalent” to a predicate device in terms of intended use,technological characteristics, and performance testing, as needed. Forinformation on how to prepare and submit a 510(k), see Device Advice Premarket Notification[510(k)].
一些I类和大多数II类器械需要510（k）。在510（k）中，根据需要，提案人必须证明新器械在预期用途，技术特性和性能测试方面与判定器械“基本上等同”。有关如何准备和提交510（k）的信息，请参阅器械建议上市前通知[510(k)]。
Some Class I and Class II devices are exemptfrom 510(k) if they do not exceed the limitations of exemption stated in 21 CFRxxx.9, where xxx refers to 21CFR 862-892. For example, an elastic bandageclassified under 21CFR 880.5075 is exempt from premarket notification, providedthat it does not exceed the exemption limitations stated in 21CFR 880.9.
如果某些I类和II类设备不超过21 CFRxxx.9中规定的豁免限制，则其豁免510（k），其中xxx指21CFR 862-892。例如，根据21CFR880.5075分类的弹性绷带免除上市前通知，条件是其不超过21CFR880.9中规定的豁免限制。
Most Class III devices require a PMA. A PMAis the most stringent type of premarket submission. Before the FDA approves a PMA,the sponsor must provide valid scientific evidence demonstrating reasonableassurance of safety and effectiveness for the device’s intended use.
大多数III类器械需要PMA。PMA是最严格的上市前提交类型。在FDA批准PMA之前，申办者必须提供有效的科学证据，证明对器械的预期用途的安全性和有效性的合理保证。
For information on how to prepare and submita PMA, see Device Advice Premarket Approval (PMA).
有关如何准备和提交PMA的信息，请参阅器械建议上市前批准（PMA）。
De Novo provides a means for a new device,without a valid predicate, to be classified into Class I or II if it meetscertain criteria.
De Novo为新器械提供了一种手段，没有有效判定的情况下，如果符合某些标准，则被分类为I类或II类。
For information on how to prepare and submita De Novo request, please refer to these resources:
有关如何准备和提交DeNovo请求的信息，请参阅以下资源：
· FD＆C法案，第513（f）（2）条
· Evaluation ofAutomatic Class III Designation (De Novo Process) Summaries
· 自动化III类指定评估（De Novo过程）摘要
· Evaluation ofAutomatic Class III Designation (De Novo Process)
· 自动化III类指定评估（De Novo过程）
HDE provides a regulatory path for Class IIIdevices that are intended to benefit patients with rare diseases or conditions.In order for a device to be eligible for an HDE, a sponsor must obtaindesignation as a Humanitarian Use Device (HUD), which is granted throughapplication to FDA’s Office of Orphan Products Development(OOPD).
HDE为第III类器械提供了旨在使患有罕见疾病或病症的患者受益的调节路径。为了使器械符合HDE资格，提案人必须获得指定为人道主义使用器械（HUD），该器械是通过向FDA孤儿产品开发办公室（OOPD）申请获得的。
For information on how to requestHumanitarian Use Designation, see Designating Humanitarian Use Device (HUD).
有关如何寻求人道主义使用指定的信息，请参阅指定人道主义使用器械（HUD）。
For information on how to prepare and submitan HDE application, please refer to these resources:
有关如何准备和提交HDE申请的信息，请参考以下资源：
· 21CFR814，子部分H
· Humanitarian DeviceExemption
· 人道主义豁免器械
第三步：上市前提交适当的信息
Once you have selected the correct premarketsubmission type, you must prepare the appropriate information that will beneeded. In this section, we identify resources for assistance and informationto consider when preparing your premarket submission.
一旦您选择了正确的上市前提交类型，您必须准备所需的适当信息。在本节中，我们提供协助和信息的资源，当您的器械准备上市前提交时。
资源
The FDA has developed several types ofresources to help you prepare your premarket submission. These include thefollowing:
FDA已经开发了几种类型的资源，以帮助你准备上市前提交。包括以下内容：
· Device Advice --comprehensive Web-based regulatory assistance
· 器械建议--综合Web-基于监管的协助
o To prepare a 510(k), please see PremarketNotification [510(k)]
o 准备510（k），请参阅[510(k)]上市前通知
o To prepare a PMA, please see Premarket Approval(PMA)
o 准备PMA，请参阅上市前批准（PMA）
· CDRH Learn -- video-basedseries of teaching modules, seminars, and recorded webinars that cover avariety of policy and guidance efforts
· CDRH学习 - 基于视频的一系列教学模块，研讨会和录制的网络研讨会，涵盖各种政策和指导工作
· CDRH Pre-Submission Program -- prospective applicants offuture premarket submissions may request feedback from the FDA through thisprogram. Information about this resource may be found in the FDA guidance Request for Feedbackon Medical Device Submissions: The Pre-Submission Program and Meetings withFood and Drug Administration Staff. We encourage youto read our online information and other available resources prior tosubmitting any request for feedback.
· CDRH预提交计划 - 未来上市前提交的潜在申请人可以通过该计划寻求FDA的反馈。有关该资源的信息可在FDA指导中找到医疗器械提交反馈请求：FDA工作人员提前举办计划和会议。我们鼓励您在提交任何反馈请求之前阅读我们的在线信息和其他可用资源。
准备上市前提交需考虑的信息
Design Controls: All Class II and Class III devices must be designed inaccordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Some Class Idevices are exempted from Design Controls. For guidance on Design Controls,please see: Design Control Guidance for Medical DeviceManufacturers.
设计控制：所有II类和III类器械必须按照质量体系法规（21 CFR820.30）中的设计控制进行设计。一些I类器械免于设计控制。有关设计控制的指导，请参阅：医疗器械制造商的设计控制指导。
Nonclinical Testing: The types of information and testing required to market yourdevice are determined by the device classification, mechanisms of operation,technological characteristics, and labeling. Nonclinical testing performed insupport of a premarket submission for a medical device must comply with theGood Laboratory Practices (GLPs) in 21 CFR 58.
非临床测试：销售器械所需的信息和测试类型由器械分类，操作机制，技术特性和标签决定。
支持医疗器械上市前提交的非临床检测必须符合21 CFR58中的良好实验室规范（GLPs）。
Clinical Evidence: PMAs, HDEs and some 510(k)s and De Novos require clinicalevidence. Prior to initiating a clinical study, the study sponsor may need toobtain approval of an Investigational Device Exemption (IDE) by the FDA. Thestudy will also need to be approved by the appropriate Institutional ReviewBoard (IRB). Clinical studies must comply with all applicable IDE regulationsand Good Clinical Practices (GCPs). For additional information on the IDE andGCP regulations, see Device Advice Investigational DeviceExemption (IDE).
临床证据：PMA，HDE和510（k）和De Novos需要临床证据。在开展临床研究之前，研究发起人可能需要获得FDA批准的调查器械豁免（IDE）。该研究还需要得到适当的机构审查委员会（IRB）的批准。临床研究必须符合所有适用的IDE法规和良好临床实践（GCP）。有关IDE和GCP规则的其他信息，请参阅调查器械豁免（IDE）。
Labeling: The labeling for a device must be written according tolabeling regulations and included in your premarket submission. For additionalinformation, see Device Labeling.
标签：器械的标签必须根据标签规定编写，并包含在您的上市前提交。有关其他信息，请参阅器械标签。
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
Once you have assembled the appropriateinformation necessary for your Premarket Submission, you send your submissionto the FDA and interact with FDA staff during review.
一旦集合了您的上市前提交所需的适当信息，您可以将您的提交发送给FDA，并在审核期间与FDA工作人员进行互动。
User Fees: There is a user fee associated with the submission of a510(k) or a PMA. For more information on user fees, please see Premarket Notification (510(k)) Review Fees and PMA Review Fees respectively.
用户费用：与提交510（k）或PMA相关联的用户费用。有关用户费用的更多信息，请分别参阅上市前通知（510（k））审查费用和PMA审查费用。
eCopy: Premarketsubmissions must include an electronic copy (eCopy) on a compact disc (CD),digital video disc (DVD), or a flash drive. For detailed information on eCopy,please see eCopy Program for Medical Device Submissions.
电子副本：上市前提交必须在光盘（CD），数字视频光盘（DVD）或闪存驱动器上包含电子副本（eCopy）。有关eCopy的详细信息，请参阅医疗器械提交的eCopy计划。
AdministrativeFiling Review: After a premarketsubmission is received, the FDA conducts an administrative review to assesswhether the submission is sufficiently complete to be accepted for substantivereview. Please see the Refuse to Accept Policy for 510(k)s or PMA Acceptance and Filling Review Policy.
行政备案审查：收到上市前提交报告后，FDA进行行政审查，以评估提交是否足够完整，以便进行实质审查。请参阅510（k）s的拒绝接受政策或PMA验收和审查政策填写。
Interactive Review: While a submission is under review, FDA staff communicateswith applicants to increase the efficiency of the review process. Pleasesee: Types of Communication During the Review ofMedical Device Submissions.
互动评论：在审查报告时，FDA工作人员与申请人进行沟通，以提高审核流程的效率。请参阅：医疗器械申请审查期间的沟通类型。
第五步：完成企业注册和器械列表
A device facility must register itsestablishment and list its devices with the FDA. Information about how toregister and list may be found at Device Registration and Listing.
器械设备必须注册其企业并将器械列入FDA。 有关如何注册和列出的信息可以在器械注册和列表中找到。
If a device requires premarket clearance orpremarket approval prior to marketing (i.e., the medical device is not exempt),the device firm must wait until it receives FDA clearance or approval beforeregistering and listing.
如果器械在销售前需要上市前清除或上市前批准（即，医疗器械不能免除），器械公司必须等到FDA注册和上市之前才会收到FDA的许可。
Registration of a device establishment,assignment of a registration number, or listing of a medical device does not inany way denote clearance or approval of the establishment or its products bythe FDA.
器械的注册企业，注册号码的分配或医疗器械的列表不以任何方式表示FDA对该机构或其产品的清除或批准。
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