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21 Cfr Part 803 Pdf Free


21 CFR Part 803 PDF Free




21 CFR Part 803 is the regulation that contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specifies that reports be filed on the FDA's MedWatch Form 3500A or an electronic equivalent. The regulation also defines the terms, procedures, and exemptions related to medical device reporting (MDR).




21 Cfr Part 803 Pdf Free



The purpose of the MDR regulation is to provide a mechanism for the FDA to identify and monitor significant adverse events involving medical devices. The FDA uses the information from MDR reports to take appropriate actions to protect public health, such as issuing safety alerts, ordering recalls, or requiring changes in device labeling or design. The MDR regulation also helps the FDA to evaluate the performance of medical devices in clinical settings and to identify potential device-related safety issues.


The MDR regulation applies to different entities depending on their role in the medical device industry. The following table summarizes the main reporting requirements for each entity:




Entity


Reporting Requirements




Manufacturer


Must report to the FDA within 30 days of becoming aware of any death, serious injury, or malfunction that is likely to cause or contribute to a death or serious injury involving their device. Must also submit a 5-day report if requested by the FDA or if the event requires remedial action to prevent an unreasonable risk of substantial harm to public health. Must also submit supplemental or follow-up reports as necessary.




Importer


Must report to the FDA and the manufacturer within 30 days of becoming aware of any death or serious injury involving their device. Must also report any malfunction that is likely to cause or contribute to a death or serious injury to the manufacturer.




Device user facility


Must report to the FDA and the manufacturer within 10 days of becoming aware of any death involving their device. Must also report any serious injury to the manufacturer or, if the manufacturer is unknown, to the FDA within 10 days. Must also submit an annual report summarizing all adverse events that occurred during the reporting year.




The MDR regulation also provides some exemptions, variances, or alternative forms of reporting for certain situations, such as when a device is part of a clinical trial, when a device is subject to another reporting requirement, or when a device is granted a waiver by the FDA. The FDA may also grant exemptions or variances from the MDR regulation for specific devices or classes of devices upon request.


The MDR regulation can be accessed online through the Electronic Code of Federal Regulations (eCFR) website or through the FDA website. However, if you want to download a PDF version of the regulation for free, you can use one of the following links:



  • [PDF version from eCFR]



  • [PDF version from FDA]




We hope this article has been helpful and informative. If you have any questions or comments, please feel free to contact us.




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