Live -Webinar 2014 - FDA's Current Regulatory Perspectives for IVDs and LDTs

DESCRIPTION
The US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs). FDA may soon begin to regulate LDTs as FDA is now proposing to regulate LDTs.
Clinical/medical laboratories, pathology groups, and specialty molecular and genetic testing labs have some concerns about what will be in the final rules. In addition, in vitro diagnostic device (IVD) industry has some legitimate concerns about FDA’s resources when it begins to regulate the LDTs. When various factors are taken into consideration, stakes are high for those clinical laboratory companies including those with patent-protected or proprietary-LDTs.
It becomes of paramount importance more than ever to the affected industry (medical laboratories, pathology groups, and specialty molecular and genetic testing labs) including IVD industry to understand what and how exactly FDA is proposing to regulate the LDTs.
This presentation is intended to help affected industry including IVDs get familiar with the FDA’s proposed regulation of LDTs so that the industry can be better prepared for the implementation of the proposed rules when finalized.
This presentation will provide great opportunities to get familiar with and plan to achieve compliance and sustainability when FDA begins to regulate LDTs.
Please join and have your LDT products in your laboratory under check to be compliant with the FDA’s implementation of the proposed rules when finalized.
Areas To Be Covered in this Webinar:
Statutes, Regulations and Guidance
Definitions
Medical Device Classification
Regulatory Requirements for FDA Clearance or Approval
Laboratory Developed Tests (LDTs): The Past, Present and Future
LDTs’ Classification
FDA’s Proposed Plan
FDA’s Guidance: What to Know and What to Do!
What Should Be Your Actionable Plan Ahead
How to Prepare for FDA’s Implementation of Regulating LDTs
Common Misunderstanding and Problems: How to Avoid
Achieving Compliance with Sustainability: Dos and Don’ts
PASS-IT Recommendations: Best Practices
Who will benefit:
Clinical Laboratories
Pathology Groups
Specialty Molecular Testing Labs
Specialty Genetic Testing Labs
Regulatory Affairs
Quality Professionals
Product Development Professionals
Hospital Management
Consultants
Senior Management
Contractors And Subcontractors
Anyone Interested In The Subject
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation