The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an an individual basis for certain devices.
The federal watchdog said it had previously piloted the program and found it allowed for more efficient reviews and better understanding of malfunction issues. The system also made it easier to identify related adverse events and trends because similar reports were bundled together, the FDA wrote.
“These benefits can be achieved without compromising effective surveillance and public availability of postmarket information about the devices,” the FDA wrote in its release.
The agency said that the program comes with limitations, including not applying to reportable death or serious injuries, which are still required to be sent to the FDA within 30 days, and that devices under product codes less than two years old are not eligible for the program.
The FDA said it also may still require individual reports, rather than summary reports, for devices in the program in cases where individual reports are “necessary for specific devices or from a specific manufacturer in order to address a public health issue.”
“The FDA is taking steps to advance innovation and surveillance for medical devices through the timely implementation of three new initiatives related to the recent user fee re-authorization. First, we’re streamlining the process for the reporting of device malfunctions through a summary reporting program. This will allow us to more efficiently detect potential safety issues and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.