Medical Device Reporting for Manufacturers DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration | Regulatory Doctor
WHEN AND WHAT TO REPORT[§803.3(q)]
Manufacturers must report all MDR reportable events (see definition) to FDA on Form FDA 3500A. Each manufacturer shall review and evaluate all complaints (see definition) to determine whether the complaint represents an event which is required to be reported to FDA. A separate Form 3500A is required for each device involved in a reportable event. For example, if a manufacturer receives a report from a user facility which indicates that more than one of the manufacturer’s devices may have been involved in a reportable event, a separate report for each device is required. A report is required when a manufacturer becomes aware (see definition) of information that reasonably suggests that one of their marketed devices has or may have caused or contributed to a death, serious injury, or has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Serious injury/(Serious illness) [§803.3(aa)(1)] is an injury or illness that:
- is life threatening, even if temporary in nature;
- results in permanent impairment of a body function or permanent damage to a body structure; or
- necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
A malfunction [§803.3(m)] is a failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
- the chance of a death or serious injury occurring as a result of a 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;
- it causes the device to fail to perform its essential function and compromises the device’s therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences. 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;
- it involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used;
- the device is considered life-supporting or life-sustaining, and thus essential to maintaining human life; or
- the manufacturer takes or would be required to take action under section 518 or 519(f) of the FD&C Act as a result of the malfunction of the device or other similar devices.
Reporters do not need to assess the likelihood that a malfunction will recur. The regulation presumes that the malfunction will recur. Furthermore, FDA believes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show, through valid data, that the likelihood of another death or serious injury as a result of the malfunction is remote.
Malfunctions are not reportable if they are not likely to result in a death, serious injury or other significant adverse event experience.
A malfunction which is or can be corrected during routine service or device maintenance must be reported if the recurrence of the malfunction is likely to cause or contribute to a death or serious injury if it were to recur.
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WHEN NOT TO SUBMIT A REPORT [§803.22]
FDA requires only one medical device report from the manufacturer if they become aware of information from multiple sources regarding the same patient and the same event. Also, for contract manufacturers, FDA would expect only one report from either the specifications developer or the contract manufacturer for one reportable event. Nevertheless, there must be a written agreement which identifies which party is responsible for completing Form 3500A.
In addition, FDA does not require that a manufacturer submit an MDR report:
- when the manufacturer determines that the information that they received is erroneous and a death or serious injury did not occur; or
- when another manufacturer made the device.
Manufacturers should retain documentation of erroneous reports in their MDR files for two years from the date of the event or a period equivalent to the expected life of the device, whichever is longer.
Any reportable event information that is erroneously sent to manufacturer A, for a device made by manufacturer B, should be sent to the FDA (Refer to “Where to Submit Reports” in this chapter) with a cover letter explaining that manufacturer A does not make the device in question.
Again, malfunctions are not reportable if they are not likely to result in a death, serious injury or other significant adverse event experience.
TYPES OF REPORTS
There are five types of MDR reports that FDA requires the manufacturer to submit. Each type of report is to be submitted within the mandatory time frame by completing the appropriate form. MDR reports for manufacturers include a:
- 30-day report,
- 5-day report,
- baseline report,
- supplemental report, and
- annual certification.
via Guidance Documents Medical Devices and Radiation-Emitting Products > Medical Device Reporting for Manufacturers.