For example, in certain MDRs, the text of the report may include the word "death" or a related term. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The FDA reviews all medical device reports (MDRs) received. These reports, along with data from other sources, can provide critical information that helps improve patient safety. In addition, the FDA also encourages 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. Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Submitting Medical Device Reports for Devices Licensed as Biological ProductsĮach year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.
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