The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting for manufacturers.

The document is intended to provide additional clarifications regarding the incident reporting requirements set forth under the current legislation. As mentioned in previous blogs, guidance documents issued by the FDA do not introduce new rules and requirements but provide non-binding clarifications to be considered. An alternative approach could be applied, provided such an approach complies with the regulatory requirements and has been approved by the authority in advance. The present article highlights the main aspects addressed in the guidance with regard to the requirements medical device manufacturer shall fulfill.

Awareness of an Event 

One of the most important concepts used in regulations related to adverse event reporting refers to the moment manufacturers “become aware” of an event that occurred. This concept applies to determine the particular moment of time when the reporting requirements are triggered. Thus, it is vitally important for the medical device manufacturer to understand the idea behind the concept in order to be able to interpret it in a correct way since most of the reporting timelines are calculated from the moment it describes. 

According to the guidance, a medical device manufacturer is considered to have “become aware” of an incident associated with the device whenever:

  • Any of [its] employees becomes aware of information that reasonably suggests that an event is required to be reported in a 30-day report or in a 5-day report that [FDA] has requested from [the manufacturer]; or
  • Any of [its] employees with management or supervisory responsibilities over persons with regulatory, scientific or technical responsibilities (including consultants and contractors) or whose duties relate to the collection and reporting of adverse events, becomes aware from any information (including any trend analysis) that an MDR reportable event(s) necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. In this case, [the manufacturer] must submit a report no later than 5 workdays after the day that [it] become aware.  

The authority additionally emphasizes that the medical device reporting procedures employed by medical device manufacturers should clearly outline the responsibilities of other parties engaged in operations with medical devices (e.g., contractors or consultants). Moreover, if the manufacturer is subject to the Quality System (QS) regulation, it should have a special unit responsible for complaints, while all other employees should forward any and all complaints received without undue delay to this unit for further review. 

“Information That Reasonably Suggests”, “Caused or Contributed”, “User Error” 

Another important concept related to the medical device reporting requirements is the concept of “information that reasonably suggests” that an incident subject to reporting has occurred. According to the guidance, this means any information, including professional, scientific, or medical facts, observations, or opinions that would cause [the manufacturer] to come to a reasonable conclusion that a device has caused or may have caused or contributed to an MDR reportable event. The concept “caused or contributed” usually applies in the case of serious injury resulting from the failure of a medical device to operate as intended, its malfunction, or any error associated with the manufacture, labeling, or user error. The latter stands for an error that occurred due to the use of a medical device in the wrong way by the person using it. According to the guidance, this could be a result of issues with the labeling or design of the product. Hence, it is also subject to reporting in the same way as other incidents associated with the medical device itself. In such cases, manufacturers should pay special attention to the incidents associated with medical devices intended to be used outside the clinical environment (e.g., at home). However, the requirement to file a report could be waived if the manufacturer determines that the event occurred solely due to the mistakes committed by the person using it. At the same time, this does not release the manufacturer from its obligations to duly keep information about such an incident in its files to be able to provide it to the authority once requested. 

MDR Submission 

The document further describes in detail how medical device incident reporting should be performed. According to the guidance, a submission filed by the manufacturer should be based on an electronic equivalent of Form 3500A. Thus, the reports related to individual adverse events should be filed to the authority in electronic format, except when a special exemption applies. 

The guidance also outlines the scope of information to be included in the report. It is stated that it should include any information:

  • That [the manufacturer] can obtain by contacting a user facility, importer, or other initial reporter;
  • That is in [its] possession; or
  • That [it] can obtain by analysis, testing or other evaluation of the device.   

The FDA further refers to separate guidance documents dedicated to the way the forms should be completed. 

The reporting requirements related to the number of medical devices to be included in one report are different for manufacturers and healthcare institutions. In particular, in the case of an incident subject to reporting involving several medical devices, the healthcare institution is allowed to submit one report covering all the devices. At the same time, medical device manufacturers are obliged to submit separate reports for each medical device, even if they are involved in the same incident. Thus, if the manufacturer receives an initial report covering several medical devices involved in a single incident, the manufacturer shall duly split it into several device-specific reports unless it can determine that only one device has caused or contributed to the event. Under the general rule, medical device manufacturers shall review any and all complaints received in order to evaluate whether the mandatory reporting criteria are met, and the incident described therein is subject to reporting. Such reports could be received via different means of communication and from different parties involved in operations with medical devices. In certain cases, the reports will be received directly from the FDA, as it can forward reports submitted by healthcare institutions and users to the manufacturers responsible for medical devices in question. All employees, consultants, and contractors of the manufacturer should be informed to forward any information related to the adverse events to the dedicated unit or responsible person. This is especially important since, as mentioned, the regulating authority considers the manufacturer to become aware of a reportable incident as soon as any of its employees become aware of it. 

In summary, the present FDA guidance provides additional clarifications on the interpretation of the regulatory requirements related to adverse event reporting. The document describes the main concepts used in legislation and provides recommendations regarding the measures the manufacturers shall take to achieve and sustain compliance with the requirements set forth therein. 


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