FDA 不良事件管理法规.doc

.Code of Federal RegulationsTitle 21, Volume 8Revised as of April 1, 2015CITE: 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 for 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 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 manufacturer, 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 incidents, 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 title 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 terms 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., 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 services 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 accredited 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，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 requested 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 reporting 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。）不良事件申报原则如果你是一个制造商，你认为已经意识到一个事件时，你的任何员工知道成为一个可报告事件，必须在30天内报告或 需要报告的5个工作日内，因为我们要求的报告按照803.53（b）。你也被认为是一个事件，当你的员工与管理或监督责任的人与监管，科学，或技术的责任，或其职责涉及的不良事件的收集和报告，意识到，从任何信息，包括任何趋势分析，这一报告的MDR事件需要补救措施防止对公众健康的重大损害的不合理的危险。(3) If you are an importer, 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 by you within 30 days.（进口商发现不良事件，需要在30天内汇报）如果你是一个进口商，你认为已经意识到一个事件时，你的任何员工知道成为一个可报告事件，需要报告的30天之内你。Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:（造成死亡或严重伤害的，或是由器械（设备）造成，或可能由器械造成，包括事件发生的结果：）造成或造成死亡或严重伤害的原因，或可能已被归因于医疗设备，或医疗设备是或可能是一个因素死亡或严重受伤，包括发生的结果：(1) Failure; 失败(2) Malfunction; 故障(3) Improper or inadequate design; 设计缺陷(4) Manufacture; 制造(5) Labeling; or 标签信息错误(6) User error. 用户使用错误什么样的情况定义为不良事件Device user facility means a hospital, ambulatory surgical facility, nursing home（疗养院）, outpatient （用户可以是医院、门诊、护理院）设备用户设施指一家医院，门诊手术设施，护理院，门诊diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physicians office, as defined in this section. School nurse offices and employee health units are not device user facilities.（诊断设备，或本节定义的门诊设施，不是指医生的办公室，科研机构和员工的及安康单位不属于用户）诊断设施，或本节所定义的门诊治疗设备，这不是医生的办公室，在本节中定义的。学校的护士办公室和员工的疗养院不是设备的用户设施。Distributor means any person (other than the manufacturer or importer) who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.（分装者亦属于生产商）经销商是指任何人（除了制造商或进口商）谁能从生产到最终交付的人或销售给最终用户的原始位置设备的营销，但谁不重新包装或改变容器，包装或标签的装置或器件封装。如果你重新包装或改变容器，包装或标签，你是一个制造商在本节中定义。Expected life of a device means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified end of life (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.设备的预期寿命意味着一个设备被放置在使用后将保持功能的时间。某些植入物指定了“植入期限”（EOL）日期。其他设备都没有标记为各自的停产，但预计将通过活动，如维修、修理或升级保持运行，为估计时间。FDA, we, or us means the Food and Drug Administration.Five-day report means a medical device report that must be submitted by a manufacturer to us under 803.53, on FDA Form 3500A or an electronic equivalent approved under 803.14, within 5 work days.五天的报告意味着医疗设备报告，必须提交由制造商，我们在，在FDA或批准在803.14电子版，5个工作日内。（制造商在发现设备的设计缺陷应在5个工作日内按照FDA803.53规定按照表3500A或者在803.14批准的电子版格式申报）制造商在发现设计缺陷申报期限Hospital means a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (e.g., not a part of a provider of services or any other facility) or may be operated by another medical entity (e.g., under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal or local government or whether it is accredited by a recognized accreditation organization.（ If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.如果不良事件符合报告标准，医院必须报告该事件，不管医疗机构提供的医疗服务的性质或位置。）Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device.（生物制品也属于医疗器械）Importer means any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.任何进口商在进口产品在交付使用时，必须保证是原始设备，任何重新包装或分装的，也是按照制造商管理Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of this chapter.故障是指设备的故障，以满足其性能规格或以其他方式执行。性能规格包括所有的索赔，在标签的设备。设备的预期性能是指在本章801.4中所定义的用于该设备被标记或销售的用途。Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:制造商指任何制造、准备、传播、化合物、组装或处理某设备的化学、物理、生物或其他过程的人。这个词包括任何一个人：(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;重新包装或改装的产品应在标签上注明原厂(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;（因为重新包装后，包装规格（剂量？）发生变化）为随后由该规范的人发起的后续发行装置所制造的设备的规格；？(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or（生产商制造的零件或配件，是是耗材，或是定制的由医护人员使用的设备或满足特定的患者？）制造设备或附件，是准备使用的设备，并打算是商业分布，并打算使用，或由执业或其他合格的人处理，以满足特定病人的需要；或？(4) Is the U.S. agent of a foreign manufacturer.是美国代理的外国制造商Manufacturer or importer report number. Manufacturer or importer report number means the number that uniquely identifies each individual adverse event report submitted by a manufacturer or importer. This number consists of the following three parts:制造商或进口商报告号码不良事件报告的编号。制造商或进口商报告号码是指制造商或进口商提交的每一个单独的不良事件报告的数量。此号码由以下三部分组成：(1) The FDA registration number for the manufacturing site of the reported device, or the registration number for the importer. If the manufacturing site or the importer does not have an establishment registration number, we will assign a temporary MDR reporting number until the site is registered in accordance with part 807 of this chapter. We will inform the manufacturer or importer of the temporary MDR reporting number;美国食品药品管理局注册号为该设备的制造地点，或进口商的注册号码。如果制造现场或进口商没有设立登记号码，我们将分配一个临时的MDR报告数直至网站与本章807部分按照注册。我们将通知制造商或进口商临时MDR报告数；申报的注册码，注册码的解释(2) The four-digit calendar year in which the report is submitted; and提交报告的四位数字日历年；及(3) The five-digit sequence number of the reports submitted during the year, starting with 00001. (For example, the complete number will appear as follows: 1234567-1995-00001.)年提交的报告的五位序列号，从00001开始。（例如，完整的号码将显示如下：1234567-1995-00001。）报告编号方式MDR means medical device report.MDR是指医疗器械报告。MDR reportable event (or reportable event) means:MDR报告的事件（或可报告事件）的手段：(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or（用户意识到器械已经或可能造成导致死亡或严重伤害）一个事件，用户设施的意识，合理地表明，一个设备已经或可能造成或导致死亡或严重伤害；或(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:（制造商意思到设备需要合理改进）一个事件，制造商或进口商意识到，合理的建议，他们的一个销售设备：(i) May have caused or contributed to a death or serious injury, or可能造成或导致死亡或严重伤害，或(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.（设备再次发生故障，制造商发现可能导致死亡或严重伤害。应当定义为不良事件）发生故障，装置或类似装置销售由制造商或进口商将可能引起或导致死亡或严重伤害，如果故障再次发生。报告手段（医疗单位汇报流程）Medical personnel means an individual who:医务人员指个人（发现（不良事件的）医务人员）(1) Is licensed, registered, or certified by a State, territory, or other governing body, to administer health care;具有国家、地区或其他管理机构的许可、注册、认证，以管理医疗；（该人员所属单位，（发生不良事件的医疗机构）(2) Has received a diploma or a degree in a professional or scientific discipline;在专业或科学学科的学位或学位；（发现的人对该产品的专业程度）(3) Is an employee responsible for receiving medical complaints or adverse event reports; or负责接受医疗投诉或不良事件报告的员工；或（指单位负责人）(4) Is a supervisor of these persons.是这些人的主管Nursing home means:护理机构(1) An independent entity (i.e., not a part of a provider of services or any other facility) or one operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing: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）或一个由另一个医疗单位（例如，共同的所有权，在执照，或一个实体控制），经营为主要目的：(i) Skilled nursing care and related services for persons who require medical or nursing care;(ii) Hospice care to the terminally ill; or(iii) Services for the rehabilitation of the injured, disabled, or sick.（一）对需要医疗或护理的人提供熟练的护理及相关服务；（二）临终关怀的临终关怀；或（三）为受伤、伤残或生病的康复服务。(2) A nursing home is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature or location of the medical service provided by the nursing home.无论是联邦政府、州政府、市政府、地方政府，还是认可认证机构的认证，都要受此规定的监管。如果一个不良事件符合报告标准，该护理之家必须报告该事件，不论其提供的医疗服务的性质或位置。（无论机构大小，均需要申报）Outpatient diagnostic facility. (1) Outpatient diagnostic facility means a distinct entity that:门诊诊断设备。（1）门诊诊断设施指的是一个不同的实体：(i) Operates for the primary purpose of conducting medical diagnostic tests on patients,(ii) Does not assume ongoing responsibility for patient care, and(iii) Provides its services for use by other medical personnel.（一）经营医疗诊断测试的主要目的是对病人进行诊断，（二）不承担对病人护理的持续责任，以及（三）提供其他医务人员使用的服务。(2) Outpatient diagnostic facilities include outpatient facilities providing radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in vitro testing. An outpatient diagnostic facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.门诊诊断设施包括门诊设施提供照相、摄影、超声、心电图、磁共振成像、计算机断层扫描，并在体外测试。门诊诊断设备可以是独立的（即不是一个部分提供服务或任何其他设备）或其他医疗单位操作（例如，共同的所有权，在执照，或一个实体控制）。本规例所涵盖的门诊诊断设备，不论其是否由联邦、州、市、或地方政府授权，或是否由认可认可机构认可。如果一个不良事件符合标准报告，门诊诊断设施必须报告，事件的性质或位置的医疗服务提供的门诊诊断设施。Outpatient treatment facility means a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or in a home health care setting. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain control, dialysis, speech or physical therapy, and treatment for substance abuse. An outpatient treatment facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.门诊治疗设备是一个独立的实体，用于提供非手术治疗的主要目的（医疗、职业、或物理）护理门诊的基础上，或在家庭健康护理的环境。门诊治疗设施包括救护车服务提供者、救援服务和家庭医疗保健组。通过门诊处理设施提供服务的例子包括：心脏除颤、化疗、放射治疗、疼痛控制、透析、演讲或物理治疗，和药物滥用的治疗。门诊治疗设备可以是独立的（即不是一个部分提供服务或任何其他设备）或其他医疗单位操作（例如，共同的所有权，在执照，或一个实体控制）。一个门诊治疗设施，无论是由联邦，州，市，