In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, says Dr. Jeffrey E. Shuren, MD, JD, director of CDRH.
“First, we have formally ended the Alternative Summary Reporting (ASR) Program. 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 to instead submit quarterly summary reports of such events,” says Shuren.
Since the program’s inception in 1997, FDA has granted 108 of these exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to healthcare professionals and patients. Shuren says that the ASR Program allowed FDA to more efficiently review reports of well-known, well-understood adverse events, enabling the agency to “focus on identifying and taking action on new safety signals and less understood risks.”
To formally end the program, 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 FDA from 1999 to 2019.
Shuren says 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.
“Our goal is to make MDR data more usable and easier to find, furthering our efforts to increase transparency in medical device reporting. In fiscal year (FY) 2019, Congress provided funding that enabled us to begin implementation of the new systems,” he says. “The president’s FY 2020 budget includes a request for additional funding for this Digital Transformation Initiative.”
This type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified, or biased data, says Shuren. Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection and is a primary focus for FDA.
Shuren notes that the National Evaluation System for Health Technology (NEST) — in development since 2012 — is designed to use real-world data in part to rapidly identify and help address safety signals once devices are on the market through active surveillance.
“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,” he says.
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