Quality Smart Solutions
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains obligatory necessities for manufacturers, importers, and device client offices to report certain device-related unfriendly occasions and item issues to the FDA. The regulation indicated that reports be recorded on the FDA's Medwatch Form 3500A or an electronic same. The FDA distributed the last rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic arrangement that the FDA can measure, survey, and document. This rule will be compelling as of Aug.14, 2015.