FDA aims to clarify device malfunction summary reporting requirements

Regulatory NewsRegulatory News | 08 December 2022 |  By 

In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain medical devices on a quarterly basis.
The agency first piloted a program to allow class I and II medical device manufacturers to report malfunctions to the agency on a quarterly basis in 2015. Following the Medical Device User Fee Amendments (MDUFA IV) negotiations, FDA formalized the Voluntary Malfunction Summary Reporting (VMSR) program in 2018.
FDA explains in the guidance that it receives more than two million medical device reports (MDRs) annually that detail suspected device-related deaths, serious injuries and malfunctions, with malfunctions making up the majority of such reports. Allowing sponsors to aggregate voluntary reports and submit them on a quarterly basis instead of on a rolling basis may be more efficient and useful to all stakeholders, according to FDA.
“FDA has determined that for many devices, it is appropriate to permit manufacturers to submit malfunction summary reports on a quarterly basis, for certain malfunctions related to devices with certain product codes, instead of individual, 30-day malfunction reports,” said the agency. “FDA’s VMSR Program is intended to yield benefits for FDA, the public, and manufacturers, such as increasing transparency for the public, helping FDA to process certain malfunction reports more efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers.”
FDA notes that only manufacturers of devices with eligible product codes can submit MDRs on a quarterly basis through the VMSR program.
“Manufacturers may ‘self-elect’ to participate in the VMSR Program by submitting summary malfunction reports for eligible product codes, and do not need to submit a separate application to FDA to participate,” the agency adds. “Participation in the VMSR Program is not required, and manufacturers of devices within eligible product codes may continue submitting individual, 30-day malfunction reports … if a manufacturer chooses to do so.”
Product codes that have only been available for the past two years are generally not eligible to participate in the VSMR program, as regulators want more time and detailed information to understand potential malfunction events. The agency says it will continue to evaluate new product codes after two years to determine if they are appropriate for the program. The agency adds that it will periodically evaluate other product codes to reevaluate their eligibility status based on new information.
In its draft guidance, FDA proposes how it will conduct periodic evaluations for product eligibility into the program and consider eligibility requests from manufacturers to participate in the program.
The agency also lists circumstances and types of events that would require individual reporting. Reportable deaths and serious injuries must be reported individually under 5-day or 30-day timeframes. Other circumstances that require individual reporting include malfunctions associated with a 5-day report, when a reportable malfunction is the subject of a class I or II recall, when FDA determines that individual MDR reporting is necessary to address a public health issue and when a new type of reportable malfunction occurs for a device. FDA further explains that it may determine that a specific device manufacturer may not participate in the program for various reasons, including failing to comply with applicable MDR requirements or failing to follow the conditions of the VMSR program.
FDA says the VSMR program is based on a set of principles that it hopes will ensure efficiency without compromising patient safety or transparency.


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