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As the medical device industry continues to mature, regulators are placing a growing emphasis on risk mitigation and post-market observation of medical devices. This includes placing some of the burdens for post-market device surveillance and reporting onto the medical device companies that manufacture devices. In 2016, the FDA published new MDR regulations that require device manufacturers, importers and device user facilities to report certain device-related events to the FDA.
Medical device manufacturers, importers and device user facilities all have separate and distinct requirements when it comes to reporting medical device adverse events. The MAUDE database contains all of the mandatory medical device reports that have been filed by manufacturers and importers since August 1996 and is a publicly available resource on the FDA website. Below, we describe the FDA medical device reporting requirements as they apply to each group:
Manufacturers - Medical device manufacturers are required to file a report with the FDA whenever they learn that one of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report device malfunctions when they believe that a death or serious injury could occur if the malfunction were to happen again with another device.
Importers - Importers must make a report to the FDA when they learn that one of their imported devices may have caused or contributed to a death or serious injury. However, when an importer learns of a device malfunction that could cause or contribute to a death if it happened again, the importer is only required to report that malfunction to the manufacturer - not to the FDA itself. The manufacturer would then be required to submit the appropriate report to the FDA.
Device User Facilities - Hospitals, ambulatory surgical clinics, nursing homes, physician offices, and any outpatient treatment facility are all examples of device user facilities. This catch-all term encompasses any context or location where medical devices are routinely used. Device user facilities must report suspected medical device-related deaths to both the FDA and the device manufacturer. If a medical device is suspected to have caused a serious injury, it must be reported to the manufacturer, or to the FDA if the manufacturer cannot be readily identified.
The FDA sets different reporting requirements for manufacturers, device importers and device user facilities when it comes to submitting adverse event reports in a timely fashion.
Device user facilities must submit a report no later than 10 days after becoming aware of a reportable event. Importers must submit a report within 30 days of becoming aware of a reportable event. Once a medical device manufacturer becomes aware of a reportable death, serious injury or malfunction, it has 30 days to report the adverse event to the FDA.
In some cases, the FDA may submit a special request that requires a manufacturer to file a report within 5 days of a reportable event. The five-day report is also required in cases where the reportable event requires immediate remedial action to prevent a risk of substantial harm to the public.
Form FDA 3500A is used to file medical device adverse event reports and can be found on the FDA website.
In addition to reporting certain adverse events, manufacturers are also required to maintain complaint files and procedures for evaluating and reviewing complaints. Greenlight Guru's Quality Management software platform provides a fully traceable trail for any customer complaints, enabling medical device manufacturers to prove that they filed device reports in compliance with the FDA regulations, initiated corrective and preventive actions when needed and did their due diligence to ensure the safety of end users.
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