U.S. Food and Drug Administration06.24.19
In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
First, we have formally ended the Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of certain devices could 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 to instead submit quarterly summary reports of such events. Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.
To formally end the program, we’ve issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes. The agency also posted ASR data submitted to the FDA from 1999 to 2019.
While ASR reports were submitted to the FDA for review, in an effort to increase transparency, in 2017 we modified the conditions of the ASR Program to require manufacturers to also submit a “companion” medical device report so that some information collected through the ASR program would be visible publicly in our MAUDE database. Each companion report includes the total number of events that are being summarized for that quarter and is publicly available and searchable in MAUDE. Important details about the content and format of the ASR data being made available are on the MDR Data Files page.
Since 2017, we have taken steps to gradually sunset the ASR Program and to streamline medical device reporting as we implemented the Voluntary Malfunction Summary Reporting (VMSR) Program. The VMSR Program reflects a pilot program conducted in response to changes made in the Food and Drug Administration Amendments Act of 2007 and goals agreed to as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) process. The FDA implemented the VMSR Program after we had conducted the pilot study that demonstrated to us the value of the program to public health.
The VMSR Program enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. This voluntary program allows manufacturers 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. Importantly, reports of a death or serious injury are not allowed to be submitted via the VMSR Program and the FDA may still require individual malfunction reports—instead of summary reports—for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.
The FDA also intends to make MAUDE more user friendly in the next few years as part of a broader effort to modernize the medical device program’s information technology systems. Our goal is to make MDR data more usable and easier to find, furthering our efforts to increase transparency in medical device reporting. In Fiscal Year (FY) 2019, Congress provided funding that enabled us to begin implementation of the new systems. The President’s FY 2020 budget includes a request for additional funding for this Digital Transformation Initiative.
As we are making these important changes to our medical device reporting program, it’s important to note that medical device reports submitted to the FDA are only one source we use to monitor marketed medical devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified or biased data. Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA, as noted in our April 2018 Medical Device Safety Action Plan.
For this reason, the FDA has worked since 2012 to develop the National Evaluation System for health Technology (NEST) – to systematically use real-world data in part to rapidly identify and help address safety signals once devices are on the market through active surveillance. Active medical device surveillance will better protect patients by, for example, 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.
Implementing a national surveillance system that allows the FDA to actively monitor device performance and patient safety would not be possible without the FDA’s establishment of a unique device identification (UDI) system, in which medical devices are marked on their labels with a unique code that can be used to identify the device through its distribution and use in patients. Device identifiers are stored in a public database, which now contains more than 2 million device records and enables patients and health care professionals to download information about their devices. The agency also has engaged in international efforts to facilitate a harmonized approach to adoption of UDI systems worldwide.
Taken together, we believe these steps will improve our ability to identify and address device safety signals and provide patients and health care professionals with important information they can use to make better informed health care decisions. We look forward to providing updates in the future about our progress in this and other areas.
First, we have formally ended the Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of certain devices could 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 to instead submit quarterly summary reports of such events. Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.
To formally end the program, we’ve issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes. The agency also posted ASR data submitted to the FDA from 1999 to 2019.
While ASR reports were submitted to the FDA for review, in an effort to increase transparency, in 2017 we modified the conditions of the ASR Program to require manufacturers to also submit a “companion” medical device report so that some information collected through the ASR program would be visible publicly in our MAUDE database. Each companion report includes the total number of events that are being summarized for that quarter and is publicly available and searchable in MAUDE. Important details about the content and format of the ASR data being made available are on the MDR Data Files page.
Since 2017, we have taken steps to gradually sunset the ASR Program and to streamline medical device reporting as we implemented the Voluntary Malfunction Summary Reporting (VMSR) Program. The VMSR Program reflects a pilot program conducted in response to changes made in the Food and Drug Administration Amendments Act of 2007 and goals agreed to as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) process. The FDA implemented the VMSR Program after we had conducted the pilot study that demonstrated to us the value of the program to public health.
The VMSR Program enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. This voluntary program allows manufacturers 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. Importantly, reports of a death or serious injury are not allowed to be submitted via the VMSR Program and the FDA may still require individual malfunction reports—instead of summary reports—for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.
The FDA also intends to make MAUDE more user friendly in the next few years as part of a broader effort to modernize the medical device program’s information technology systems. Our goal is to make MDR data more usable and easier to find, furthering our efforts to increase transparency in medical device reporting. In Fiscal Year (FY) 2019, Congress provided funding that enabled us to begin implementation of the new systems. The President’s FY 2020 budget includes a request for additional funding for this Digital Transformation Initiative.
As we are making these important changes to our medical device reporting program, it’s important to note that medical device reports submitted to the FDA are only one source we use to monitor marketed medical devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified or biased data. Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA, as noted in our April 2018 Medical Device Safety Action Plan.
For this reason, the FDA has worked since 2012 to develop the National Evaluation System for health Technology (NEST) – to systematically use real-world data in part to rapidly identify and help address safety signals once devices are on the market through active surveillance. Active medical device surveillance will better protect patients by, for example, 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.
Implementing a national surveillance system that allows the FDA to actively monitor device performance and patient safety would not be possible without the FDA’s establishment of a unique device identification (UDI) system, in which medical devices are marked on their labels with a unique code that can be used to identify the device through its distribution and use in patients. Device identifiers are stored in a public database, which now contains more than 2 million device records and enables patients and health care professionals to download information about their devices. The agency also has engaged in international efforts to facilitate a harmonized approach to adoption of UDI systems worldwide.
Taken together, we believe these steps will improve our ability to identify and address device safety signals and provide patients and health care professionals with important information they can use to make better informed health care decisions. We look forward to providing updates in the future about our progress in this and other areas.
