The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and Center for Devices and Radiological Health has updated and released the final guidance "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers" to streamline and simplify the reporting of device malfunctions by manufacturers.
The FDA has issued this guidance to assist manufacturers in understanding and utilizing the Voluntary Summary Malfunction Reporting (VMSR) Program. Under this voluntary program, manufacturers can report malfunctions related to certain product codes every quarter to FDA in a summary format.
In addition to increasing transparency for the public, FDA's VMSR Program will facilitate FDA's ability to process certain malfunction reports efficiently, enable both FDA and the public to identify malfunction trends more readily, and reduce the burden on manufacturers.
FDA requires sufficient detail in summary reports to understand reportable malfunctions.
Summary malfunction reporting should use a common format for electronic reporting.
Information about reportable malfunctions must be transparent to FDA and the public, with protected information redacted.
Manufacturers must report imminent hazards as early as possible.
Summary reporting streamlines malfunction reporting but does not alter MDR investigation or recordkeeping requirements.
Summary reports should not duplicate information from other MDR reporting processes.
By participating in the VMSR Program, manufacturers of eligible product codes may report certain device malfunction MDRs in summary form quarterly instead of submitting individual MDRs for reportable malfunction events. By submitting summary malfunction reports for eligible product codes, manufacturers can “self-elect” to participate in the VMSR Program without having to submit a separate FDA application.
The VMSR Program offers several benefits to both manufacturers and the FDA:
Efficiency: By allowing summary reporting, the program reduces the administrative burden on manufacturers, enabling them to focus on device safety and quality.
Enhanced Monitoring: The FDA can more easily identify trends and potential safety issues through the consolidated data provided in summary reports.
Flexibility: The voluntary nature of the program allows manufacturers to opt in based on their specific needs and circumstances.
For detailed guidance on the VMSR Program, including eligibility criteria and reporting procedures, please refer to the full FDA Guidance Document.
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