Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.
Why should you Attend: The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. The overall intent of this program, just like FAA for passenger safety is to provide critical information that helps improve patient safety.
Areas Covered in the Session: As mentioned above, the FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. We are going to talk at length about Customer Complaints a little later in this presentation. Each manufacturer must establish and maintain procedures to control all documents that are being used for the generation and distribution of medical devices.
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