2021 - Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

Day 01(11:00 AM - 6:00 PM EDT)
UNITED STATES
Session 1
Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
Why the regulators need separate regulations even IVD is considered a device?
Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
Morning Break
Session 2:
Overview of US-FDA Regulations for IVDs
Lunch Break:
Session 3:
Determination of classification & Identification of Predicate Device(s)
Development of Regulatory Strategies and Pathways for IVDs
Special consideration of IVD labeling requirements
Afternoon Break:
Session 4:
Determine the type of the required pre-market submission for your IVD
Format and Content of 510(k), Pre-IDE, IDE and PMA
What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
Preparation and submission for CLIA Waiver Application
Day 02(11:00 AM - 6:00 PM EDT)
EUROPE
Session 5:
Overview of European IVD Regulations
Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
Morning Break:
Session 6:
Special consideration to Classification Rules for IVDs
Conformity Assessment for CE Marking
Special Labeling and electronic Labeling Requirements for IVDs
Preparation of Technical File or Design Dossier
Lunch Break:
CANADA
Session 7:
Overview of Canadian Medical Device Regulations (CMDR) for IVDs
Understanding similarities and differences between U.S. and Europe regulations
Afternoon Break:
Session 8:
Format and Content of Canadian Medical Device License (MDL) Application
Inclusion of the required data and information for MDL application
Conclusion & Summary of the course