Overview
AssurX eMDR is designed to help medical device companies transition from their cumbersome and inefficient manual MedWatch processing to electronic medical device reporting (eMDR).

By using an intuitive, tabular workflow approach, generating and submitting MedWatch 3500A reports has never been easier. AssurX eMDR process is a fully functional regulatory reporting process that provides all levels of 3500A reporting, seamless direct submission to the FDA’s ESG (Electronic Submissions Gateway), as well as PDF generation.

Manual MedWatch 3500A Submission Process

The current process is low-tech, manual and inefficient. Each report submitted is manually re-entered into the MAUDE database by FDA data entry contractors. As of February 6, 2008, the FDA stopped accepting faxed-in MedWatch reports.

AssurX eMDR: Key Features—Built-in, right out of the box

• Automated reporting to the FDA
• Conforms to the FDA’s HL7 submission schema
• Complete server-to-server solution (via FDA’s AS2 Gateway)
• Self-contained -- no other software to buy
• Rigorously tested with the FDA
• Can be used as a standalone process or integrated with any other processes within CATSWeb (complaint handling, CAPA, NCMRs, etc.), or other vendors’ complaint handling systems (e.g., Oracle/Siebel CRM)
• Easy viewing of all submitted MDR status
• EDI functionality built-in. No separate system to purchase, install or validate

The benefits of submitting through the FDA’s Direct AS2 gateway-to-gateway are many.

• No more couriers or mailings for MedWatch reports
• Submission of eMDR will eliminate the need for double entry by FDA staff, ensuring your data is received exactly the way you submitted it
• You’ll increase efficiency, consistency and productivity by having all your complaint handling and reporting information in a single and compliant repository
• Report submission is performed all within a single application vs. having to create a file that needs to be uploaded manually
• eMDR provides a comprehensive closed-loop system to not only track complaints, but also ensure proper follow ups, as well as integrate seamlessly to the rest of the quality management system (NCMRs, Audits, CAPA, etc.)
  

eMDR - How it works

1. The FDA ESG receives an eMDR submission from the manufacturer 2. FDA ESG sends Acknowledgement 1 to the manufacturer/submitter (confirming the submission was successfully received by the FDA ESG. Also Contains a Message Integrity Check to validate that the submission was received intact.) 3. Submission is automatically transferred to the FDA Center 4. FDA ESG sends Acknowledgement 2 indicating the submission passed message integrity checks and was forwarded to CDRH 5. CDRH validates and processes the submission 6. CDRH sends Acknowledgement 3 indicating the submission was successfully loaded into the Adverse Event database, or noting any errors that occurred during validation / loading