Shuren Discusses Device Reporting Changes

CDRH has ended its Alternative Summary Reporting (ASR) program and issued revocation letters to 13 remaining manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes. Under the program, certain device makers 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,” CDRH director Jeff Shuren says in an online post. Recently, the program has been criticized for lacking transparency about certain adverse event reporting (see story).

“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,” Shuren says. “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.” As part of the program’s closing, FDA has just now posted ASR data submitted to FDA from 1999 to 2019.

To replace the ASR program, CDRH has implemented its Voluntary Malfunction Summary Reporting (VMSR) program. This “allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis, for eligible device types,” Shuren says. “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.”

Additionally, Shuren says the agency 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,” he says. “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.”