Best Practices for MDRs, Recalls, Corrections, and Removals

Duration: 60 Minutes
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Medical Device Reporting
Instructor: David Lim
Product ID: 500042
MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish (define, document and implement) adequate procedures for MDRs, recalls, corrections and removals.

This webinar is intended to help device industry establish adequate procedures for MDRs, recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements. At the end of the webinar, you will leave actionably motivated in a way that you would plan, develop and execute the relevant procedures in a holistic manner.

Objectives of the Presentation:
  • Applicable statutes and FDA regulations
  • Regulatory requirements for MDRs, recalls, corrections and removals
  • Definitions
  • How to report medical device adverse events
  • Reporting requirements for the user facilities, manufacturers, and importers
  • Recalls, corrections and removals (devices)
  • Voluntary recalls and mandatory device recalls
  • How to perform and document corrections and removals
  • Checklist
  • Enforcements: case studies
Who can Benefit:
  • CEOs
  • VPs
  • Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)
  • Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs)
  • Quality Professionals (Associates, Specialists, Managers, Directors or VPs)
  • R&D (Engineers, Scientists, Managers, Directors or VPs)
  • Complaint and risk management personnel
  • Consultants
  • Contractors/Subcontractors
  • Other Interested Parties
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Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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