FDA Closes Alternative Summary Reporting Program

Posted June 26, 2019

In a move intended to increase transparency in medical device adverse event reporting, the Food and Drug Administration (FDA) has shuttered its Alternative Summary Reporting (ASR) Program, a program that for two decades has allowed some medical device manufacturers to provide the agency with quarterly summary reports of medical device adverse events.

The ASR program drew public criticism earlier this year following a Kaiser Health News report that described it as “so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety” including former FDA commissioner Robert Califf, according to the report. Most of the reports filed under the program were not available to the public, despite some describing “serious injury and malfunctions.”

In closing the program, the FDA also released a public database containing six million ASR reports for the past 20 years, fulfilling a promise made by outgoing FDA Commissioner Scott Gottlieb.

“We appreciate the value to the public in ensuring this information from medical device reports is readily available to them,” said FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a joint statement. “This program was established in 1997 to more efficiently review adverse events for well-established risks but was not allowed for patient deaths and unusual, unique, or uncommon adverse events … alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE).”

According to the FDA, the agency has been gradually phasing out ASR to “streamline medical device reporting” and implement the Voluntary Malfunction Summary Reporting (VMSR) Program. That program allows manufacturers to report certain device malfunctions in summary form on a quarterly basis for eligible device types, in reports that are publicly available in MAUDE.

“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,” said Shuren. “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.”