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Mar 2015


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Laboratory Developed Tests under FDA's Thumb - webinar by Compliance4all

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Event Overview: 

The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.

You will learn how reporting regulations, such as FDA's manufacturing regulations (Quality System Regulation (21 CFR Part 820), Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806) would apply to LDTs. Once you identified the regulatory obligations, the logistical issues will be discussed and the types of game plans that may be necessary. 

Why Should you Attend: FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests by licensed clinicians. This brings to mind some very practical questions? How do physicians change the logistics of their practice? How can clinical institutions provide specialized care when their tools are taken away? FDA regulation hammers specialized medical practices by throwing the process into a regulatory mill. A test developed by the doctor would now require production by manufacturer, who is subject to layers and layers of regulatory controls. As a consequence, there is no useful or timely turn around for supplying special in vitro reagents. Can the doctor order, receive and use a special reagent the same day now? 

Healthcare institutions treatment protocols and purchasing contracts will require a massive overhaul. Do physicians abandon tests that they had come to rely on for a proper diagnosis or treatment recommendation? Are manufacturer's ready to create a process that meets FDA's manufacturing and reporting regulations for novel diagnostics for such special products? Will manufacturers be obligated to make products that are not cost effective for them? These stakeholders are coming to a face off. Manufacturers, doctors and health care institutions need to have practical game plan to fill the gap. 

Areas Covered in the Session:

  • Reasons for FDA regulation
  • Applicable regulations
  • Use and availability of LDTs
  • Identify logistical risks
  • Steps for implementation

Who Will Benefit:

  • Clinical laboratories
  • Pathology practice groups
  • Medical institutions (hospitals) using Laboratory Developed Tests
  • Practitioners
  • Healthcare maintenance organizations
  • Medical device and diagnostic manufactures
  • Risk managers for healthcare practices
  • Regulatory affairs managers for IVD manufacturers
  • Cost control consultants for healthcare practices

Speaker ProfileCasper Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. 


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