On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published 20 years of reports submitted through the ASR Program that had not previously been disclosed to the public, leaving manufacturers with potentially massive amounts of data to sort through regarding their products.
Background of the ASR Program
Created in 1997, the ASR Program was designed to give FDA more time to review and act on “new safety signals and less understood risks” by relieving FDA of the obligation to review well-known and well-understood adverse events. Under the ASR Program, manufacturers could request an exemption from the burden of submitting individual reports and instead submit quarterly summary reports for common adverse events. Since the ASR program’s inception, FDA has granted 108 exemptions for specific, well-known adverse events associated with medical devices, such as adverse events those described in the labeling of the device.
FDA Ends ASR Program to Increase Transparency
The ASR Program caused some concern among the public because very few of the reports submitted to the FDA through this program were accessible to the public. In 2017, FDA took steps to make the ASR program more transparent by requiring manufacturers to submit dual reports. Along with their ASR reports, FDA asked manufacturers to submit a “companion” MDR that would be available to the public through the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database holds mandatory reports (submitted by manufacturers, importers, and device user facilities) and voluntary reports (submitted by healthcare professionals, patients, and consumers) that the entire public can access. In 2018, FDA also began to slowly phase out the ASR Program when it launched the Voluntary Malfunction Summary Reporting (VMSR) Program.
The VMSR Program was also designed to reduce FDA’s monitoring burden. Under the VMSR Program, manufacturers of specific medical devices can report certain malfunctions on a quarterly basis in a summary format rather than through individual reports. When FDA ended the ASR Program, only 13 companies still had VMSR exemptions. These included manufacturers of dental implants, implantable cardiac defibrillators, and pacemaker electrodes. In an effort to increase transparency regarding safety of medical devices, FDA decided to end the ASR Program and release 20 years of reports that were filed under the ASR Program.
Further Steps Taken by FDA to Improve Transparency
FDA has also been working to make the MAUDE system more user-friendly and to modernize the Medical Device Programs Information Technology Systems. Since 2012, FDA has been working on the National Evaluation System for health Technology (NEST). This active surveillance system uses real-world data to quickly find and address safety signals once devices are on the market. NEST is designed as a counterpart to the MDR Program, with the intent of removing the human error that can come through reports. These actions demonstrate FDA’s commitment to making records more transparent and giving the public a more open view into its regulatory activities.
Implications
Medical device manufacturers should monitor FDA’s push for transparency and the potential impact transparency may have on their businesses. With the release of 20 years’ worth of ASR Program data, 6 million previously undisclosed adverse event reports are open now to public scrutiny. Morrison & Foerster’s new FDA practice and our product liability lawyers can help you assess the potential impact of these reports on your company.
[1] Shuren, Dr. Jeffery E. “Statement on agency’s efforts to increase transparency in medical device reporting.” U.S. Food & Drug Administration, 21 June 2019, https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting