Enhancing Collaboration with the FDA through MedWatch Plus

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 MedWatch Plus initiative comes in.

The FDA originally provided medical device reporting through the use of MedWatch forms (forms 3500 and 3500A). The MedWatch initiative began as a manual process and has recently evolved into a fully automated Web-based process, called MedWatch Plus, 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.

This paper will give an overview of the FDA's MedWatch Plus program as well as the benefits and best practices of using the FDA's Gateway.