FDAs 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

PRESS RELEASE

THE DARK REPORT
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FOR IMMEDIATE RELEASE

Media Contact: Ron Martin
rbmartin@darkreport.com

 

AUSTIN, Texas (August 28, 2014) — On July 31, the Food and Drug Administration sent its 60-day notice to Congress that it is moving forward to regulate laboratory-developed tests (LDTs). The clock is now ticking down the minutes until laboratories throughout the U.S. will need to comply with a host of new requirements.

Although some medical laboratories may subscribe to the strategy to simply sit back and wait for the FDA to put guidelines in place, it’s widely acknowledged that failure to answer key questions now could spell disruption of a laboratory’s delivery of LDT test results to clients, not to mention triggering financial chaos and possibly subjecting the lab to enforcement action by the FDA, a very powerful federal agency.

“It will benefit clinical labs and pathology groups greatly to understand what is already known about the FDA’s plans—and to use that knowledge to get a head start on packaging their lab’s LDTs to obtain speedy FDA clearance ahead of hundreds of other labs,” said Robert L. Michel , Editor-In-Chief of The Dark Report. “To help labs at this critical moment, we are offering a timely and illuminating new webinar, hosted by a panel of consulting and legal veterans who are already up to speed with the FDA’s draft guidance that it delivered to Congress on July 31, at the same time that it notified lawmakers that it intended to regulate LDTs. What the FDA cannot discuss about LDT regulation, our experts can, and will.”

This webinar, entitled  “FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now” is being presented on Wednesday, September 17, 2014 at 1:00 PM EDT. The respected hosts of this web conference not only have their fingers on the pulse of the lab testing industry, they 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 phone lines 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 darkdaily.com/LDTwebinar    You may also contact Ron Martin at 512-264-7103.

About THE DARK REPORT

Established in 1995, THE DARK REPORT  is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely-read by leaders in laboratory medicine and diagnostics. The DARK REPORT produces the famous Executive War College on Laboratory and Pathology Management (every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals), Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.

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