FDA Finalizes Voluntary Program for Reporting Device Malfunctions

The FDA has granted an alternative to individual reporting requirements for manufacturers of Class I and II devices that are not permanently implantable, life supporting or life sustaining.

The Voluntary Malfunction Summary Reporting Program will allow the manufacturers of devices with eligible product codes to voluntarily submit quarterly summaries of malfunction reports. It gives eligible manufacturers an alternative to submitting MDRs when they encounter a device malfunction.

The program will reduce the burden on manufacturers and the agency by reducing the amount of MDRs submitted.