Understanding FDA Enforcement and Regulation of Laboratory Developed Tests (LDTs)

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

FDAs Next Step to Regulate LDTs is intended to Explain How Exactly FDA Proposes the Regulations. Learn How to be Compliant with the Implementation.

It has been long since the US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs). Now, FDA is proposing to regulate LDTs. The Clinical/medical laboratories, pathology groups, and specialty molecular and genetic testing labs are having 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 by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to help affected industry including IVDs to 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. Furthermore, the presentation will provide great opportunities to get familiar with and plan to achieve compliance and sustainability when FDA begins to regulate LDTs. Join the power-packed conference to have LDTs in your laboratory under check and be compliant with the FDA’s implementation of the proposed rules when finalized.

Training Objective:

  • Laws and Regulations
  • Definitions
  • Current Medical Device Classification
  • Regulatory Requirements for FDA Clearance or Approval
  • Background on LDTs
  • Classification of LDTs
  • Whose Stakes Are High with Awareness
  • FDA’s Proposed Plan Over Time
  • FDA’s Guidance
  • What Should Be Your Actionable Plan Ahead
  • How to Prepare for FDA’s Implementation of Regulating LDTs
  • Achieving Compliance with Sustainability: Dos and Don’ts
  • PASS-IT Recommendations: Best Practices

Who Should Attend

  • Clinical Laboratories
  • Pathology Groups
  • Specialty Molecular Testing Labs Professionals
  • Specialty Genetic Testing Labs Professionals
  • Regulatory Affairs Professionals
  • Quality Professionals
  • Product Development Professionals
  • Hospital Management Professionals
  • Consultants
  • Senior Management
  • Contractors and Subcontractors

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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