Medical device product fault reporting the to the US FDA

by | May 23, 2023 | IMed Consultancy, PMS, USA

Article 120_Europe

Do I need to report a medical device product fault to the US FDA?

In the unfortunate event that an undetected manufacturing defect is found in a medical device, or there is an error in the use of the product, or other safety problems are encountered during the product’s use by clinicians and patients and these result in a ‘serious incident’ such as injury or death, regulations require reporting to the regulator in the country where the issue occurred.

In this article, we will focus on the key considerations for Medical Device Reporting in the USA. The first point to consider on whether reporting is required is that the US medical device regulator, FDA, requires that safety events that occur in any country and may reoccur on the same device, or a similar device that is sold into or used in the USA are evaluated for reportability. This is different from most other countries, which typically only require reporting of safety issues that have happened in their own country.

The first step in determining whether the problem could be reportable is looking at the FDA definition of what is a “reportable event” summarised as;

An event has occurred that reasonably suggests that a manufacturer’s 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.

One way of evaluating reportability is to evaluate the risk to health, by identifying:

  1. Do the details, on investigation, show the patient has died or may have been seriously injured by the incident?
  2. In the device risk analysis (e.g., ISO 14791), could the hazardous situation encountered result or contribute to a death, serious injury, or medical intervention to prevent serious injury according to the severity of harm scoring?

If the answer to either of these questions is yes, a report to the FDA is likely to be required. FDA has published a useful guidance document, which should be used to help manufacturers determine whether a device problem needs to be reported to them. Reporting needs to be completed within 30 calendar days of the manufacturer becoming aware of the problem occurring, and first be reporting which starts the clock ticking is often to a member of sales, servicing, and other customer-facing teams so timely and effective transfer of problem information to complaint evaluation personnel is recommended.

Reporting is performed using an electronic system, which can sometimes take several days and significant time to set up correctly – so pre-emptive action is advised to set up the FDA reporting tools before they are required to be used.

Many manufacturers will not complete the full investigation before the 30 calendar day reporting deadline, particularly if the device needs to be returned for investigation. In this case, manufacturers typically submit an initial report to the FDA detailing the facts and investigation progress as known at the time of submission. A second supplementary report after the investigation has concluded is then submitted.

The FDA publishes a summary of all submitted reports on a regulatory database called MAUDE, which can be freely accessed and searched by all. Therefore, in any reports submitted consider the tone and content of reporting, as certain data elements submitted become public information. These reports form useful information for competitors, industry, and academia for evaluating device-specific, and device-type faults, hazards, and the health effects those events have on patients.

Find out how IMed Consultancy can support you in evaluating your reporting needs and ensuring your reports satisfy requirements in the US by contacting

Tim Bubb

Tim Bubb

Technical Director

Click here to learn more about our Medical Device Services: