Webinar on FDA’s New eMDR Requirements

Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA became increasingly difficult over time. The FDA announced its development of an electronic format for submitting Medical Devices Reports. The final rule for requiring the submission of electronic MDRs was announced and has gone into effect. All MDRs submitted by manufacturers and importers must be accomplished through the FDA’s Electronic Submissions Gateway (ESG). 

Areas Covered in the Session :

• MDRs reporting elements for
  • Manufacturers
  • Importers
  • User facilities
• New eMDR program requirements
  • eSubmitter program
  • HL7 electronic submissions
  • Electronic Submissions Gateway (ESG) account
  • Operational deadlines
  • eMDR rejections 
• Revisions to related postmarket programs
  • Quality Assurance coverage
  • Training
  • Corrective and Preventive Actions
• Enforcement

Who Will Benefit:

• Device manufacturers
• Device importers
• User facilities
• FDA consultants
• Domestic and international regulatory affairs managers
• Q.A. managers / training
• Complaint and MDR managers
• Data processing managers
• 3rd party complaint managers