Since 2017, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health https://www.fda.gov/medical-devices has been taking steps to update their “Medical Device Reporting” (MDR) program. The goal is to make the MDR program more usable and easier to find.
Congress has provided funding to enable FDA to begin implementing new systems. The President’s FY 2020 budget includes a request for additional funding for this “Digital Transformation Initiative”.
The funding will be used to upgrade changes to the MDR system. The future for active surveillance to utilize real world data is to develop up to date medical device safety signal detection which is FDA’s primary focus.
The FDA is also working to make the “Manufacturer and User Facility Device Experience” (MAUDE) https://open.fda.gov/data/maude more user friendly in the next few years as part of a broader effort to modernize the medical device program’s IT systems.
Since “Voluntary Malfunction Summary Reporting” (VMSR) was implemented, manufacturers are now allowed to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis for eligible device types. Reports from this voluntary program are publicly available in the MAUDE database.
Since 2012, FDA has worked to develop the “National Evaluation System for Health Technology (NEST) to systematically use real world data to rapidly identify and to help address safety signals once devices are on the market through active surveillance.
Active medical device surveillance will better protect patients by continuously using analytical software algorithms to evaluate large data sets on device performance and patient safety associated with device use in routine clinical practice. In FY 2019, Congress provided funding to begin to develop active surveillance capabilities for NEST.
FDA has also established the “Unique Device Identification” (UDI) where medical devices have labels marked with a unique code that can be used to identify the device through distribution and use in patients.
Device identifiers are stored in a public database containing more than two million device records and allows patients and healthcare professionals to download information about their devices. The agency is also engaged in international efforts to facilitate a harmonized approach to the adoption of UDI systems worldwide.