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This document provides general guidance regarding the reporting of adverse events required by the Medical Device Reporting MDR Regulation. This requirement no longer exists. Therefore, the submission of an event by a health care professional does not require the manufacturer to report the event based solely on the statements of a health care professional. The event must meet the reporting criteria in MDR to qualify as a reportable event.
Five-day reports are required in two circumstances. First, they are required if a manufacturer becomes aware that a reportable event, from any source of information, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Second, five-day reports are required when a manufacturer becomes aware of an MDR reportable event for which FDA has requested a five-day report.
Firms must submit MDR reports when the reported information reasonably suggests an association between one of its devices and a reportable death, serious injury or malfunction. Under some circumstances, an adverse event may appear to trigger the requirement of submission of an MDR, but because information reveals the device did not cause or contribute to the death or serious injury, no MDR is required. Thus as described below, a manufacturer will have to investigate the event in order to know if it should be reported.
A firm is required to submit an MDR report when it becomes aware of information reasonably suggesting that an event meets the criteria for reporting a Death, Serious Injury, or Malfunction. For example, a hospital informs a manufacturer that its device has failed and, as a result, a patient died.
At this point, the firm has become aware of information that reasonably suggests they are in receipt of a reportable MDR event. Next, the firm must investigate the report to determine its cause. During its investigation a firm may become aware of information that changes the initial report's conclusions. For example, the firm may find that its device was not involved in the death and could not have caused or contributed to the death. In these instances the firm would document the information that changes the association between its device and the death.
No report would be required if the death or other facts turn out to be incorrect. However, if the firm's investigation does not change the alleged association between the device and the death, the event must be submitted as an MDR report.
In addition, if the firm's investigation produces information that would cause a person who is qualified to make a medical judgment to reach a reasonable conclusion that the device did not cause or contribute to a reportable MDR event - no report is required. Translation - if a firm decides NOT to report an apparent device-related death, serious injury or malfunction - this decision must be made by a person that the regulation recognizes as qualified to make a medical judgment, i.
Using the example from above, if the firm's investigation yields an autopsy finding that the patient died from cancer — not the device - the firm could decide NOT to report as long as the decision is consistent with the regulation:. If the firm cannot obtain the missing information, the MDR complaint files shall contain an explanation of why the information could not be obtained as well as documentation of the firm's efforts to obtain the missing information.
A firm must demonstrate that it exercised "good faith" in any failed attempts to obtain required data that is missing, incorrect, or that FDA considers to be reasonably known. While the concept of good faith is generally considered to be equivalent to "due diligence", CDRH has not developed a standard. However, the firm's procedures for obtaining missing information should appear under the "Internal Systems" section of its written MDR procedures. The interpretation of what constitutes a serious injury can be subjective and complicate the enforcement of MDR.
The "unanticipated temporary impairment" part of the former serious injury definition has been rescinded, thus alleviating a source of subjectivity. In addition, the requirements that intervention be "immediate" and the concept of "probability" have also been removed from the serious injury definition. If there is no injury attributable to the device, then there is no serious injury report, however, the event may qualify as an MDR reportable malfunction depending upon the circumstances.
The Center may decide to clarify the definition of serious injury. Malfunction reporting decisions have been the subject of concern by both industry and the FDA. Basically, a malfunction is an event that is likely to cause or contribute to either a death or serious injury, but some circumstance prevented the injury or death from occurring.
These events are very important since they represent "potential" deaths or serious injuries and provide the Agency with the opportunity to be proactive in reducing risks. Not all malfunctions, however, are MDR reportable events. If a malfunction is not reportable as an MDR, it may be a complaint and thus subject to the QS complaint handling requirements.
Determining if an event is a reportable malfunction involves answering a number of questions including:. There is a presumption in the MDR regulations that if the event happened once it can happen again. The determination of whether to submit a report should be based on the potential outcome. For example, if this malfunction were to occur, how would it affect the patient? If the answer is "the malfunction is likely to cause or contribute to death or serious injury" then the event is reportable.
The preamble to the MDR regulations Federal Register: December 11, , Volume 60, Number , pages offers the following guidance for determining circumstances in which malfunctions should be reported.
NOTE: Envelopes must be specifically identified with the type of report enclosed, e. The information can come from any source. Devices that "may have caused or contributed" to a death or serious injury; or a malfunction that would be likely to cause or contribute to a death or serious injury must be reported. Reasonably known: Firms must provide all information that is reasonably known to them. FDA considers the following to meet this standard, i.
Information required to be reported: The form FDA A is the primary reporting form for death, serious injury and malfunction events. With the exception of drug or biologic related items, all the fields must be completed or have an entry NA, NI, or UNK indicating why the information could not be obtained. Missing Information: Manufacturers are responsible for obtaining and providing FDA with any information that is missing from reports that are received from user facilities, distributors, and other initial reporters.
If a firm cannot provide complete information, it must provide a statement explaining why such information was incomplete and the steps taken to obtain the information.
Any required information not available at the time of the report, obtained at a later date, must be forwarded to FDA in a supplemental report within one month of receipt. Investigation: Manufacturers are responsible for investigating and evaluating the cause of each event. These investigations must follow the requirements in 21 CFR Five-Day Reports - Baseline Reports - Baseline Reports must be updated annually if information changes on the firm's scheduled registration date, as required by Part Baseline Reports, only sections 21 CFR Supplemental Reports - Using the example from above, if the firm's investigation yields an autopsy finding that the patient died from cancer — not the device - the firm could decide NOT to report as long as the decision is consistent with the regulation: There is documented information that changes the association between the death and the device, The decision is made by a person who is qualified to make a medical judgement, and The conclusion reached by the person in item two is reasonable.
Individuals who are not qualified to make a medical judgement can review MDR reports and make decisions on the basis of facts but they cannot make decisions NOT to report MDR events that require medical judgement. In lieu of in-house or on-site qualified medical personnel or individuals qualified to make a medical judgement the firm may use consultants. When reviewing a non-reportable event validate and document the credentials of the individual making these decisions as well as the decision not to report the event.
Determining if an event is a reportable malfunction involves answering a number of questions including: Is the event device-related? Has the device failed to perform its intended function or meet its performance specifications?
Is this failure likely to cause or contribute to a death or serious injury if the event were to happen again? The preamble to the MDR regulations Federal Register: December 11, , Volume 60, Number , pages offers the following guidance for determining circumstances in which malfunctions should be reported The chance of a death or serious injury occurring as a result of the recurrence of the malfunction is not remote; The consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury; The malfunction results in the failure of the device to perform its intended essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness, which could cause or contribute to a death or serious injury.
NOTE: The essential function of a device refers, not only to the device's labeled use, but for any use widely prescribed within the practice of medicine. The malfunction involves a long-term implant or a device that is considered to be life-supporting or life-sustaining and thus is essential to maintaining human life. Malfunctions of long-term implants are not routinely or "automatically" reportable unless the malfunction is likely to cause or contribute to a death or serious injury if it recurs.
The manufacturer takes or would be required to take an action under sections or f of the Act as a result of the malfunction of the device or other similar devices.
FDA FORM 3417
U.S. Food and Drug Administration