This article deals with mandatory reporters like manufacturers, importers, device user facilities and voluntary reporters who each submit medical device 510k reporting to the FDA. Medical device reports are a post market monitoring method used to track the functionality of devices, identify possible safety concerns, and contribute to benefit-risk analyses of these items. Mandatory reporters are required to submit particular types of reports on adverse incidents and product problems involving medical devices 510k reporting by FDA.
Required Reporting Requirements for Medical Device
Manufacturing: Manufacturers must report to the FDA when they learn that their devices may have caused or contributed to a death or serious injury, or if they are aware of a malfunction.
Importers: Importers must report to the FDA and manufacturer if they learn that a device’s malfunction has caused or contributed to a death or serious injury.
Device User Facilities: User facilities are hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities. They must report a suspected medical device-related death to both the FDA and the manufacturer, or to the FDA if the medical device manufacturer is unknown.
The FDA also promotes the voluntary reporting of significant adverse events that may be connected to a medical device by consumers, patients, caregivers, and healthcare professionals. MDRs offer important data that enhances patient safety. However, there are issues with this passive surveillance system, such as underreporting of incidents, inaccurate reports, and a lack of proof that the device was the cause of the claimed event.
Manufacturer, Importer, and Device User Facilities Required Reporting (Form FDA 3500A):
You may find details and guidelines for required device reporting at:
- Medical Device Adverse Event Reporting for Producers, Importers, and Device Users
- Voluntary Malfunction Summary Reports Program Guidelines
- Guidelines for Filling Up Form FDA 3500A
- Electronic Medical Device Reports, or eMDR
- Guidelines for Industry and Food and Drug Administration Staff Regarding Medical Device Reporting by Manufacturers
- Medical Device Reports for User Facilities: FDA Guidelines
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Source: Medical Device Reporting (MDR): How to Report Medical Device Problems | FDA
