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FDA Tells Congress It Intends to Regulate LDTs! Web Conference to Provide Straight Talk on Essential Steps Clinical Laboratories and Pathology Groups Will Need to Take to Comply
Date:9/2/2014

also possess hands-on experience helping their clients work with the FDA on obtaining clearance for IVD tests, medical devices, and similar products.

Distinguished presenters:
Jane Pine Wood, Attorney and Partner, McDonald Hopkins 
Kuo Tong, President & CEO, Quorum Consulting, Inc. 
Richard S. Cooper, Attorney and Partner, McDonald Hopkins 

The insights that will be offered during this webinar comprise essential information needed by laboratories to help them develop a game plan for LDTs. Presenters will share information with attendees about specific issues, in addition to opening up the session for live Q&A:

  • Why labs should not wait, but will benefit from decisive action now

  • Whether private payers will require FDA clearance of LDTs before issuing coverage and reimbursement determinations

  • How much of its existing steps for medical device review the FDA will incorporate into its LDT review requirements

  • Developing the business case for LDT clearance with lab owners and investors

  • Addressing the cost of LDT compliance

  • Timing of getting LDT tests to market

For more information about "FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now" and to view webinar details including presenter biographies and pricing, visit www.darkdaily.com/LDTwebinar. You may also contact Ron Martin<
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SOURCE The Dark Report
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