The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health has undertaken significant steps to revise its Medical Device Reporting (MDR) Programme.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
MDR Programme is a major tool used by the regulator to monitor device performance, identify potential device-related safety concerns or signals and conduct benefit-risk assessment of the products.
The FDA has ended the Alternative Summary Reporting (ASR) Programme, which allows manufacturers of certain devices to request an exemption from the requirement to file individual medical device reports for certain events that were well-known and well-established risks associated with a particular device and submit quarterly summary reports of such events.
The programme has helped the regulator to effectively assess reports of well-known and well-understood adverse events, helping to identify and take actions on new safety signals and less understood risks.
FDA has issued letters to the remaining 13 manufacturers with ASR exemptions to formally end the programme. It covered three kinds of devices such as dental implants, implantable cardiac defibrillators and pacemaker electrodes.
In 2017, the FDA modified the conditions of the ASR Programme, which made manufacturers to submit a companion medical device report that is available to the public via MAUDE database.
Each companion report is comprised of total number of events, which are being summarised for that quarter.
Since 2017, the FDA has taken steps to gradually end the ASR Programme and streamline medical device reporting through the Voluntary Malfunction Summary Reporting (VMSR) Programme.
The VMSR is a pilot program carried out to support changes made in the FDA Amendments Act of 2007 and goals agreed to as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) process.
FDA implemented the VMSR Program upon completion of VMSR Programme’s pilot study, which demonstrated the significance of the programme’s value to public health.
The VMSR Programme allows the FDA to identify detect potential safety signals, as well as helps resources to better focus on addressing the highest risks such as deaths and serious injuries associated with medical devices.
In addition, the voluntary programme enables manufacturers to report certain device malfunctions in summary form on a quarterly basis instead on an individual basis for eligible device types.
Since 2012, the FDA has been involved in the development of National Evaluation System for health Technology (NEST) to systematically use real-world data to quickly identify and help address safety signals once devices are on the market through active surveillance.
The unique device identification (UDI) system has helped the FDA to mark medical devices with a unique code, which can be used to detect the device through its distribution and use in patients.