Adverse event reporting
Medical Device Reporting is the requirement to tell FDA when a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would be likely to cause one if it happened again. The obligation falls differently on manufacturers, importers and user facilities, and it continues for the life of the device on the market.
21 CFR 803; FDA MDR guidance for manufacturers, November 2016
At a glance
| The regulation | 21 CFR Part 803. |
|---|---|
| Manufacturer, standard deadline | 30 calendar days from becoming aware of a reportable death, serious injury or malfunction. |
| Manufacturer, urgent deadline | 5 work days where the event needs remedial action to prevent unreasonable risk of substantial harm to public health, or where FDA has asked in writing. |
| Importer | 30 calendar days. Deaths and serious injuries to FDA and to the manufacturer. Malfunctions to the manufacturer only. |
| User facility | 10 work days. Deaths to FDA and to the manufacturer if known, serious injuries to the manufacturer. User facilities do not report malfunctions. |
| Distributor | Must maintain records of incidents. Not required to report them. |
| Foreign manufacturers | Subject to the regulation and must submit required reports. |
| "Work day" | Monday to Friday, excluding federal holidays. 5 work days is not 5 calendar days. |
The three triggers
A serious injury is an injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude such permanent impairment or damage. Permanent means irreversible, excluding trivial impairment or damage.
A malfunction is the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling. A malfunction is reportable where it, or the same malfunction in a similar device, would be likely to cause or contribute to a death or serious injury if it recurred.
Caused or contributed means a death or serious injury was, or may have been, attributed to a device, or the device was or may have been a factor. FDA lists six ways this can arise: failure, malfunction, improper or inadequate design, manufacture, labeling, or user error.
Note the last one. User error is on FDA's own list.
30 calendar days, or 5 work days
A manufacturer must report no later than 30 calendar days after the day it receives or otherwise becomes aware of information, from any source, that reasonably suggests a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would be likely to do so if it recurred.
"From any source" is doing real work in that sentence. The clock starts on awareness, not on confirmation.
A 5 work day report is required where a reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, or where FDA has made a written request for one.
FDA states that awareness of the need for remedial action may come from any information, including trend analysis. Where FDA has made a written request, the manufacturer must submit 5-day reports for all subsequent events of the same nature involving substantially similar devices, for the period FDA specifies, without further requests.
Questions people ask
Do events outside the United States have to be reported?
Yes, in defined circumstances. FDA considers a foreign event reportable where it involves a device cleared or approved in the United States, or a device similar to one the manufacturer markets there, and the device is lawfully marketed in the foreign country.
What if we are not sure the device caused it?
The standard is information that reasonably suggests the device may have caused or contributed. Certainty is not required, and the definition of "caused or contributed" expressly covers events that may have been attributed to the device.
Do distributors report?
No. Distributors must maintain records of incidents but are not required to report them.
Is 5 work days the same as one week?
No. Work day means Monday to Friday excluding federal holidays. A US public holiday inside the window extends it, and the calendar week may not.
Does an MDR failure affect anything besides the reporting itself?
Yes. Failure to comply with section 519 of the FD&C Act, which MDR implements, makes the device misbranded under section 502(t)(2).