June 21, 2019

CDRH Provides Statement on Efforts to Increase Transparency in Medical Device Reporting

June 21, 2019—The FDA Center for Devices and Radiological Health (CDRH) issued a statement from Director Jeffrey E. Shuren, MD, announcing the steps being taken to update the CDRH Medical Device Reporting (MDR) Program and promote public transparency. The FDA uses the MDR to monitor device performance, detect potential device-related safety concerns or signals, and contribute to the benefit-risk assessment of these products.

In the statement, Dr. Shuren commented, “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.” Dr. Shuren's complete statement is available on the FDA's website here.

Among other steps, the agency has:

  • Formally ended the Alternative Summary Reporting (ASR) program, which has been gradually retired since 2017. 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 instead submit quarterly summary reports of such events. The FDA granted 108 such exemptions since the program's inception in 1997. To formally end the program, the agency has issued revocation letters to the remaining 13 manufacturers with ASR exemptions.
  • Publicly posted the ASR data submitted from 1999 to 2019.
  • Implemented the Voluntary Malfunction Summary Reporting (VMSR) program to streamline medical device reporting. The VMSR program enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks associated with medical devices, such as deaths and serious injuries. 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 Manufacturer and User Friendly Device Experience (MAUDE) database.
  • Prepared plans 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.
  • Secured funding from Congress in fiscal year 2019 to begin developing active surveillance capabilities for 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.
  • Developed a unique device identification (UDI) system to effectively implement NEST to actively monitor device performance and patient safety. The agency also has engaged in international efforts to facilitate a harmonized approach to the adoption of UDI systems worldwide.

According to Dr. Shuren, the agency's goal is to make MDR data more usable and easier to find, thereby increasing transparency in medical device reporting. In addition to the 2019 funding from Congress to begin implementation of the new systems, the president’s fiscal year 2020 budget includes a request for additional funding for this digital transformation initiative.

In the FDA statement, Dr. Shuren advised, “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.”


June 24, 2019

Medtronic and Edwards Issue Statements Supporting the CMS National Coverage Determination for TAVR

June 21, 2019

CMS Issues National Coverage Decision Updating Policy for TAVR