FDA aims to clarify requirements for summary reporting of device malfunctions

FDA aims to clarify requirements for summary reporting of device malfunctions

In new draft guidelines released Thursday, the U.S. Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit summary reports of malfunctions of certain medical devices on a quarterly basis.

The agency first piloted a program allowing manufacturers of Class I and II medical devices to report malfunctions to the agency on a quarterly basis in 2015. Following the Changes to medical device user fees (MDUFA IV), the FDA formalized the Voluntary Malfunction Summary Reporting (VMSR) program in 2018.

The FDA explains in the guidelines that it receives more than two million medical device reports (MDRs) each year that detail device-related deaths, serious injuries, and malfunctions, with malfunctions making up the majority of those reports. According to the FDA, allowing sponsors to bundle voluntary reports and submit them on a quarterly basis rather than on an ongoing basis can be more efficient and useful for all stakeholders.

“The FDA has determined that for many devices, it is appropriate to allow manufacturers to submit malfunction summary reports on a quarterly basis, for certain malfunctions related to devices with certain product codes, instead of malfunction reports individual 30 days,” the agency said. . “FDA’s VMSR program is intended to provide benefits to the FDA, the public, and manufacturers, such as increasing transparency for the public, helping the FDA handle certain malfunction reports more efficiently, allowing both the FDA and the public to more easily identify malfunctioning trends, and reducing the burden on manufacturers.

The FDA notes that only manufacturers of devices with qualifying product codes can submit MDRs on a quarterly basis through the VMSR program.

“Manufacturers can ‘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 the FDA to participate,” the agency adds. . “Participation in the VMSR program is not required, and manufacturers of devices in eligible product codes may continue to submit individual 30-day malfunction reports…if a manufacturer chooses to do so.”

Product codes that have only been available for 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 reassess their eligibility status based on new information.

In its draft guidance, the FDA proposes how it will conduct periodic evaluations of product eligibility for the program and review manufacturers’ applications for eligibility to participate in the program.

The agency also lists the circumstances and types of events that would require individual reporting. Reportable fatalities and serious injuries must be reported individually within 5 or 30 days. Other circumstances requiring individual reporting include malfunctions associated with a 5-day report, when a reportable malfunction is subject to a Class I or II recall, when the FDA determines that an individual report of the MDR is necessary to resolve a public health issue and when a new type of reportable malfunction occurs for a device. The FDA further explains that it may determine that a specific device manufacturer may not participate in the program for a variety of reasons, including non-compliance with applicable MDR requirements or non-compliance with the terms of the VMSR program.

The FDA says the VSMR program is based on a set of principles it hopes will ensure effectiveness without compromising patient safety or transparency.

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