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FDA发布最终指南：医疗器械报告（MDR）

美国食品药品监督管理局（FDA）于2016年11月8日发布了最终指南文件，旨在帮助医疗器械制造商满足不良事件和故障的报告和记录保存的要求。

这份52页问答式的指南文件（其草案发布于2013年7月）取代了1997年3月发布的《医疗器械报告（MDR）指南》。

FDA表示，医疗器械报告（MDR）法规的目标是及时发现和纠正问题。本指南更新了FDA的政策并澄清了FDA对21 CFR part 803的法规要求的说明。此外，本指南中有一个章节专门讲述了常见的报告错误。

医疗器械报告（MDR）法规提供了一种机制，可以使FDA和医疗器械制造商识别和监测不良事件（死亡或严重伤害）以及器械的某些故障，以便及时发现和纠正问题。

所有在美国合法销售的医疗器械的制造商，包括向美国出口器械的国外制造商，都必须遵守医疗器械报告（MDR）法规，并且必须按要求提交报告。

根据FDA的定义，“制造商”是指通过化学、物理、生物或其他程序制造、制备、繁殖、合成、装配或加工器械的任何人，包括再包装商和器械组件或附件制造商。

此外，FDA表示，任何出于重复使用的目的对一次性使用器械进行再加工的人都是该器械的制造商，需遵守适用于原制造商的所有要求，包括医疗器械报告（MDR）法规的要求。

制造商必须向FDA提交三种类型的MDR报告，每种报告都必须在强制性时间范围内提交，三种类型如下：

然而，对于FDA认为的器械“用户错误”（或“使用错误”），也就是由使用该器械的人导致的与器械相关的错误，FDA表示，在某些情况下制造商不需要提交M

DR报告，但制造商必须在投诉文件中保留相关支撑信息。

该指南文件指出，这种错误经常反映出器械标签、用户界面和器械设计的其他方面的问题。因此，FDA认为这些事件应该与由该器械引起或造成的其他不良事件相同的报告方式向FDA报告。这对于在非医疗保健机构中使用的器械尤其重要。如果制造商确定事件仅仅是由于用户错误造成的而器械本身不存在其他性能问题，并且没有造成与器械相关的的死亡或严重伤害，制造商不需要提交MDR报告，但需在投诉文件中保留相关支撑信息。

在美国合法销售的器械的制造商，包括国外制造商，必须：

FDA认为制造商有责任告知所有员工，包括营销、销售、工程、生产、监管、法律、安装和服务人员，当发现不良事件时，应马上将相关信息传达给指定人员，并由指定人员向FDA提交MDR报告。因此，FDA通常认为，只要任何一位员工发现了不良事件，制造商就应获悉该不良事件的发生。

该指南文件还说明了：与器械相关的投诉来自哪里？什么是器械故障以及何时必须上报器械故障？什么是“严重伤害”？如何确定器械故障“有可能”引起或造成死亡或严重伤害？在什么情况下投诉可能不需要上报？合约制造商的相关信息以及一些具体问题和情况的更多信息。

Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance

07 November 2016

Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance
07 November 2016

"The US Food and Drug Administration (FDA) on Monday finalized guidance to help device manufacturers meet the reporting and recordkeeping requirements for adverse events and malfunctions.

The 52-page question-and-answer-based guidance, first drafted in July 2013, supersedes that draft and other guidance from 1997.

“The goal is to detect and correct problems in a timely manner,” FDA said on Monday. “This guidance updates FDA’s policy and clarifies FDA’s interpretations of the regulatory requirements under part 803 (21 CFR part 803) and includes a section on common reporting errors.”

Background

Under the Medical Device Reporting (MDR) regulation, there is a mechanism that allows FDA and device manufacturers to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions of devices to detect and correct problems in a timely manner.

All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to the MDR regulation and must submit required reports.

A “manufacturer,” according to FDA, is any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure, including repackagers and device component or accessory manufacturers.

In addition, any person who reprocesses a single use device for reuse becomes the manufacturer of the device and is subject to all the requirements applicable to the original manufacturer, including the requirements of the MDR regulation, FDA says.

Types of Reports

Manufacturers are required to submit three types of MDR reports to FDA, each of which must be submitted within the mandatory time frame, including reports that:

● Must be submitted within 30 calendar days after the day a manufacturer becomes aware of a reportable device-related death or serious injury, or a reportable malfunction
● Must be submitted within five work days after the manufacturer becomes aware of an MDR reportable event, including one that necessitates remedial action to prevent an “unreasonable risk of substantial harm to public health” or one for which FDA has made a written request for
● Are supplemental or follow-up reports with information unknown or unavailable to manufacturers at the time of the initial 30-day report or 5-day report
However, for what FDA considers to be a device “user error” (or “use error”), which means a device-related error or mistake made by the person using the device, FDA says manufacturers are not required to submit an MDR report in some cases, but they should retain the supporting information in complaint files.

“Such errors often reflect problems with device labeling, the user interface, or other aspects of device design. Thus, FDA believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device. This is especially important for devices used in non-health care facility settings. If you determine that an event is solely the result of user error with no other performance issue, and there has been no device-related death or serious injury, you are not required to submit an MDR report, but you should retain the supporting information in your complaint files,” the guidance adds.

Reporting Events

Manufacturers, including foreign manufacturers, of legally marketed devices in the US are required to:

●　Submit to FDA reports of MDR reportable events, which are “events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur”
● Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is a reportable event
● Establish and maintain complete files for all complaints concerning device events

FDA believes that manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Thus, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.

The guidance also explains where device-related complaints come from, what a device malfunction is and when it must be reported, what a “serious injury” is, how to decide whether a malfunction is “likely to” cause or contribute to death or serious injury, cases where complaints might not have to be reported, information for contract device manufacturers and much more on specific issues and situations."