Medwatch Plus

Overview
Medwatch Plus is a reporting portal for the public to submit adverse event reports as well as the capability to create reports to inform the public of safety problems. The FDA receives more than 600,000 voluntary postmarketing adverse event reports annually from manufacturers, health care professionals, and consumers for all FDA-regulated products, many of which are submitted as paper reports. The portal provides a user-friendly electronic submission capability, encouraging the reporting of information in a quality and uniform manner.

Source

 * Information Technology: FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks, at 17-18.