FDA803不良事件管理法规文档格式.docx

1、CITE: 21CFR803TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H-MEDICAL DEVICES PART 803MEDICAL DEVICE REPORTINGSubpart A-General ProvisionsSec. 803.1 What does this part cover? 803.1 的内容（a） This part establishes（建立） the requirements fo

2、r medical device（装置） reporting for device user facilities, manufacturers（生产商）, importers（进口商）, and distributors（经销商）. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and

3、 submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacture

4、r, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device distributor, you must maintain records （files） of incident

5、s, but you are not required to report these incidents. 本部分建立用户、制造商、进口商和分销商的医疗器械产生不良事件报告的要求。如果你是一个用户，您必须针对设备或器械造成的死亡和严重伤害进行报告，建立和维护不良事件文件，并提交摘要年度报告。如果您是一个制造商或进口商，您必须对死亡和严重伤害（事件）报告，您的设备已经或可能造成或促成，您必须报告某些设备故障，您必须建立和维护不良事件文件。如果你是一个制造商，还必须提交指定的随访。这些报告可以帮助我们通过帮助确保设备不掺假或冒牌的，是安全和有效的使用保护公众健康。如果你是一个医疗设备经销商，你必

6、须保持记录（文件）的事件，但你不需要报告这些事件。（b） This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter.这一部分的补充，不能取代本章其他规定，包括本章820部分的规定。（c） References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of t

7、itle 21, unless otherwise noted.在本部分中提到的联邦法规的法规部分是第一章我的标题21，除非另有说明。Sec. 803.3 How does FDA 美国食品药品管理局define the terms used in this part?803.3 FDA如何定义这一部分所使用的术语？Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute （law）. Other term

8、s are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:（这部分中，我们使用的术语是指特定的医疗设备，并规定了申报是语言）我们在这部分使用的术语是特定于医疗设备的报告，反映了在法规中使用的语言（法律）。其他条款更为普遍，反映了我们对法律的解释。本节定义了下列术语：Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq

9、., as amended.法案意味着联邦食品、药物和化妆品法案，21 U.S.C. 301 et seq.，修订。Ambulatory surgical facility （ASF） means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity （i.e., not a part of a provider of se

10、rvices or any other facility） or operated by another medical entity （e.g., under the common ownership, licensure, or control of an entity）. An ASF is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or regardless of whether it is acc

11、redited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.门诊手术设施（ASF）是一个独立的实体，用于向患者提供当日门诊手术服务的主要目的。ASF可以是一个独立的实体（即，不是一个部分提供服务或任何其他设备）或其他医疗单位操

12、作（例如，共同的所有权，在执照，或一个实体控制）。ASF是受这一规定无论是授权由联邦，州，市，或当地政府或不管它是由一个公认的认证机构认证。如果一个不良事件符合报告标准，ASF必须无论由ASF提供医疗服务的性质或位置报告事件。Become aware means that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred.觉察意味着要求报告实体员工获得信息的合理建议报告的不良事

13、件的发生。（1） If you are a device user facility, you are considered to认为 have become aware（意识到） when medical personnel, as defined（定义） in this section（部分）, who are employed by or otherwise formally affiliated with your facility, obtain information about a reportable event.如果您是设备用户，你被认为是有“意识”当医务人员，本节中定义的，

14、谁是受雇于或正式的附属设施，获得有关报告的事件信息。（2） If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had req

15、uested reports in accordance with 803.53（b）. You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and repor

16、ting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.（制造商发现疑是不良事件时，不管是什么渠道，必须在30天内汇报，按照803.53（b）需要5个工作日内的应及时上报，如果你确定是不良事件的，必须对收集到的信息进行分析，并对不良事件采取补救措施。）如果你是一个制造商，你认为已经