According to the FDA website, the regulatory body for medical devices in the United States receives hundreds of thousands of reports per year, detailing medical device adverse events that include device-associated deaths, serious injuries, and device malfunctions. To help collect, store and analyze this information, the FDA has instituted an electronic medical device reporting system that enables manufacturers, user facilities, importers, healthcare providers and consumers of medical devices to make reports on medical device adverse events.
The reports collected by the FDA can be broadly classified as either mandatory or voluntary reports. Manufacturers, device user facilities and importers are legally mandated to submit reports for adverse events involving medical devices within specified timelines. In addition, health care providers and consumers may choose to submit voluntary reports that offer information to the FDA about adverse events.
The FDA has published mandatory legislation for medical device reporting for manufacturers, importers
Under 21 CFR Part 803, a user facility must submit an electronic medical device report no more than 10 days after becoming aware of information suggesting that a device may have caused or contributed to the death of a patient at the facility. The same report must also be submitted to the device manufacturer. When a user facility becomes aware of an adverse event that results in serious injury, it must report the incident to the device manufacturer within 10 days, or to the FDA instead
Under 21 CFR Part 803, a medical device importer must complete a filing via the electronic medical device reporting process no more than 30 days after becoming reasonably aware that a device they marketed has resulted in a death or serious injury. The FDA specifies that the importer may learn about the adverse event from any source, including a user facility report, from the affected individual, or even in
In addition, importers must submit a report to the device manufacturer no later than 30 days after becoming aware of a medical device malfunction that could have the potential to cause or contribute to a death or a serious injury if it were to occur again.
Medical device manufacturers must submit an electronic medical device report no later than 30 days after becoming aware of information from any source that suggests a marketed device may have caused or contributed to a death or serious injury, or has malfunctioned and would pose a significant risk if the malfunction were to recur.
Mandatory electronic medical device reporting can be completed on the FDA website using FDA Form 3500.
Medical device manufacturers face the highest level of accountability when it comes to electronic medical device reporting (and additional
Medical device companies that have partnered with Greenlight Guru enjoy a distinct advantage throughout the electronic medical device reporting process. Greenlight Guru's integrated, risk-based eQMS Software makes it easy for medical device companies to assess device failures, tie adverse events back to the design features that caused them and ultimately justify the design feature through the lens of user needs and appropriate risk management or make improvements to the product.