Course Agenda
Day 1  (8:30AM-4:05PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00AM:  Overview and MDR History
  •  Overview of MDR 21CFR 803 
  • Who Must Report and Why Report
  • What is the Process and Key Definitions Like Become Aware, Failure, Malfunction Improper or Inadequate Design, Manufacture, Labeling or User Error
  • How to Report Medical Device Problems - Overview

10:00 – 10:15AM: Break

10:15 – 12:00 noon:  Reporting Requirements
  • Mandatory vs. Non-Mandatory
  • Importers
  • User Facilities
  • Manufacturers

12:00 – 1:00PM: Lunch

1:00 – 1:45PM: Group exercise: Review recent MDRs and MedWatch Reports for review and discussion

1:45 – 2:15PM: MDR Process
  • Sources for Reportable Event
  • Type of Reports Who Must Report
  • When and What to Report
  • When Not to Submit a Report
  • Types of Reports and MedWatch

2:15 – 2:35PM: Break

2:35 – 4:05PM: MDR Process - continued
  • Reports and Mandatory Timeframes
  • Reporting Codes (Coding Manual)
  • MedWatch 3500A and 3500
  • Reporting for Foreign Manufacturers
  • Reporting for User Facilities and Distributors
Day 2  (8:30AM-4:00PM)

8:30 – 10:00AM: MDR Process
  • Criteria, Timeframes, Event Problem Codes
  • FDA Requests for Additional Information
  • Where to Submit Reports
  • Where to Report a Public Health Emergence
  • English Reporting Requirements
  • Electronic Reporting
  • FDA Database Search

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Complaints and MDRs
  • What is the connection between product complaints and MDR’s
  • Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event
  • Servicing and MDRs
  • Compliance and regulatory expectations
  • MDR procedures that address the requirements in 21 CFR Part 803

12:00 – 12:45PM: Lunch

12:45 – 1:30 PM: Group exercise: Searching and Reviewing MDR’s and Reviewing MDR Procedures/Work Instructions for Group Discussion

1:30 – 2:15PM: FDA’s Final Rule Amending 21 C.F.R. Part 803, Medical Device Reporting and Additional Guidance an MDR Trends
  • e-MDR’s
  • Documentation Requirements
  • Is your MDR information is being identified, reviewed, reported, documented and filed

2:15 – 2:30PM: Break

2:30 – 4:00 PM: FDA Enforcement and Compliance Expectations and MDR Trends
  • Review FDA 483 Observations
  • Review Warning Letter Citation
  • Compliance Expectations and Industry Trends