FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now

New Webinar from The Dark Report — Wednesday, September 17, 2014

Our distinguished panel explains how the FDA’s draft guidance
is a road map that labs can follow immediately to optimize
how the FDA treats their most important LDTs

There’s big news ahead if your lab performs laboratory-developed tests (LDTs)! On July 31, the Food and Drug Administration sent its 60-day notice to Congress that it is moving forward to regulate LDTs. The clock is now ticking down the minutes until your lab will need to comply with a host of new requirements.

But, will your lab be ready? Is the right strategy to simply sit back and wait for the FDA to put the guidelines in place? Or, will it benefit your lab greatly to understand what is already known about the FDA’s plans—and use that knowledge to get a head start on packaging your lab’s LDTs to obtain speedy FDA clearance ahead of hundreds of other labs?

Failure to answer these questions correctly can spell disruption in your lab’s delivery of LDT test results to clients—not to mention triggering financial chaos and subjecting your lab to enforcement action by this very powerful federal agency. To help you at this critical moment, we are offering an exceptional learning event, “FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now” on Wednesday, September 17, 2014 at 1:00 PM EDT.

You’ll hear from a panel of consulting and legal veterans who are already up to speed with the FDA’s draft guidance that it delivered to Congress on July 31, at the same time that it notified lawmakers that it intended to regulate LDTs.

• First up will be Jane Pine Wood….
• Next is Kuo Tong…
• Pulling it all together as presenter and moderator of the live
  question and answer session is Rick Cooper…

Our respected speakers have their fingers on the pulse of the lab testing industry, plus, they have hands-on experience helping their clients work with the FDA on obtaining clearance for IVD tests, medical devices, and similar products. This is essential information you need to help your lab develop its game plan for LDTs.

As you may already know, the draft guidance the FDA provided to Congress signals that virtually every lab running LDTs will need to bring those tests into compliance with the coming regulations. For its part, the FDA says that 11,000 LDTs are performed by 2,000 labs in the United States. One of those labs may be yours!

What lies ahead for your laboratory in the realm of LDTs? In its draft guidance, the FDA writes that it intends to:

• Divide LDTs into the classes of high-risk (Class I Medical Devices), medium-risk (Class II Medical Devices), and low-risk (Class III Medical Devices)
• Establish notification to FDA or registration and listing of LDTs
• Require adverse event reporting for your lab’s LDTs
• Require pre-market review of many LDTs
• Require data and relevant information to support clinical validity of your lab’s LDTs

If there is some good news in the FDA’s draft guidance, it is the category of “traditional LDTs.” During the webinar, our panel will help you understand how the FDA views these tests and whether your lab has compliance requirements if it performs these tests.

What will add extra value to this webinar is the information
that your presenters will share with you about these specific issues:

• Why your lab shouldn’t wait, but will benefit from decisive action now
• Whether private payers will require FDA clearance of your 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 your lab’s owners and investors
• Addressing the cost of LDT compliance
• Timing of getting your LDT tests to market

Where else can you get all this information, in one place and at one time? Given the importance of LDTs to your lab, this is a “must-attend” session.

For one low price—just $195 (through 9/3/14; $245 thereafter), you and your entire team can take part in this fast-paced, insightful dialogue. Best of all, you’ll be able to connect personally with our speakers and get answers to your most pressing questions when we open up the phone lines for live Q&A.

Get straight talk on how this new FDA guidance
could impact your lab and its ability to serve patients

• How a test developers’ ability to offer tests during the review period may be affected
• Which LDTs will likely be subject to lesser oversight, and how the plan could impact cutting-edge tests
• The implications of new reporting responsibilities, including the kinds of data you will need to be prepared to provide
• And much, much more!

How to Register:

1. Register Online
2. Call toll free: 800-560-6363.

Your registration includes:

• A site license to attend the webinar (invite as many people as you can fit around your conference table at no extra charge)
• A downloadable PowerPoint presentation from our speakers
• A full transcript emailed to you soon after the conference
• The opportunity to connect directly with the speakers during the audience Q&A session

Register Now! Or for more information, call us toll-free at 800-560-6363.