Live Online Training FDA's Current Regulatory Perspectives for IVDs and LDTs

Website https://compliance2go.com/product/?pid=CP2014-398 | Edit Freely

Category Healthcare , Medical Device , Pharmaceutical

Deadline: December 03, 2014 | Date: December 03, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-11-21 16:35:35 (GMT+9)

Call For Papers - CFP

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

Certificate