FDA announces efforts to increase transparency in medical device reporting

June 26, 2019

The Food and Drug Administration’s Center for Devices and Radiological Health announced that it 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.

Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health said in a statement that FDA has formally ended the Alternative Summary Reporting (ASR) Program. Under this program, he said 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 the agency could focus on identifying and acting on new safety signals and less understood risks. 

To formally end the program, Shuren said FDA 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 the agency 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 its 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 now on the MDR Data Files page. 

Since 2017, Shuren says FDA has taken steps to gradually sunset the ASR Program and to streamline medical device reporting as it 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 conducting the pilot study that demonstrated 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. In Fiscal Year (FY) 2019, Congress provided funding that enabled FDA to begin implementation of the new systems. The FY 2020 budget includes a request for additional funding for this Digital Transformation Initiative. 

Shuren said 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. 

For further details, visit FDA.