FDA to Explore Criteria for Quarterly Medical Device Malfunction Reporting

Regulatory NewsRegulatory News | 18 August 2015 |  By 

The US Food and Drug Administration (FDA) has announced it will pilot a new initiative to explore criteria for allowing medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis.

Medical Device Malfunction Reporting

In 2007, the Food and Drug Administration Amendments Act (FDAAA) made changes to the Food, Drug, and Cosmetic Act (FD&C), requiring makers of certain class I and class II devices to report malfunctions on a quarterly basis, based on a set of criteria defined by FDA.

Specifically, the quarterly reporting requirement would apply to class I devices and class II devices "that are not permanently implantable, life supporting, or life sustaining." For class III devices and class II devices that do not meet the listed requirements, companies will still be required to submit individual malfunction reports within 30 days, as per Part 803 of Code of Federal Regulations.

Now, the agency says it is looking for companies to take part in a pilot program where device malfunction reports are submitted quarterly. The agency says the pilot will help it develop the criteria for quarterly malfunction reporting submissions in the future.

The agency says up to nine companies may take part in the pilot program, and it intends to run the pilot for six months.

Companies taking part in the pilot will be given an exemption from current malfunction reporting requirements through the duration of the pilot, though other reportable events must still be sent in the 30-day window.

Summary Reports

FDA says the quarterly reports should be in a summary format using Form FDA 3500A. The reports will include a description of the event or problem, the number of events contained in the report, as well as device identifying information and contact information for the manufacturer. Additionally, the agency requests companies:

"Provide a summary of the results of your investigation of the reported malfunctions, including the type of any remedial action taken or an explanation of why remedial action was not taken, and any additional information that would be helpful to understand how you addressed the malfunction events summarized in the report. Also enter a breakdown of the malfunction events summarized in the report, including the number of devices that were returned to you; the number of devices that were labeled for single use (if any); and the number of devices that were reprocessed and re-used (if any)."

In the pilot announcement, FDA also gives two scenarios to demonstrate the format and contents of the reports, one involving an infusion pump and a second involving multiple malfunctions pertaining to a powered bed.

Federal Register


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