The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries are produced safely and effectively. As market demand increases for the need of quick product cycles and the distribution of regulated products, the ability to react quickly to an adverse event must be considered.
As market demand increases the need for quick product cycles and the distribution of regulated products, the ability to react quickly to an adverse event must be considered. This trend has led to an initiative within the FDA to increase the ability to collaborate and communicate more quickly with reporting organizations. This is where the electronic Medical Device Reporting(eMDR) initiative comes in. The FDA originally provided medical device reporting through the use of MedWatch forms 3500 and 3500A. The eMDR initiative began as a manual process and has recently evolved into a fully automated Web-based process,which enables companies to submit both voluntary and mandatory reports in one central location through the FDA’s Electronic Submissions Gateway. This was put into place because the FDA believed one point-of-entry would better enable organizations to submit information.1 This paper will give an overview of the FDA’s eMDR program as well as the benefits and best practices of using the FDA’s Gateway.
As market demand increases the need for quick product cycles and the distribution of regulated products, the ability to react quickly to an adverse event must be considered. This trend has led to an initiative within the FDA to increase the ability to collaborate and communicate more quickly with reporting organizations. This is where the electronic Medical Device Reporting(eMDR) initiative comes in. The FDA originally provided medical device reporting through the use of MedWatch forms 3500 and 3500A. The eMDR initiative began as a manual process and has recently evolved into a fully automated Web-based process,which enables companies to submit both voluntary and mandatory reports in one central location through the FDA’s Electronic Submissions Gateway. This was put into place because the FDA believed one point-of-entry would better enable organizations to submit information.1 This paper will give an overview of the FDA’s eMDR program as well as the benefits and best practices of using the FDA’s Gateway.