Preparing for the LDT Regulation - Webinar CD/Transcript

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Preparing for the LDT Regulation: CLIA Won’t Satisfy the FDA

FDA has long asserted that design and manufacture of Laboratory Developed Tests (LDTs) falls under the device regulations. CLIA regulations apply to performing the tests and do not meet the device regulations.

Come up short in an inspection and the FDA can issue a Form 483, as recently happened with Theranos. They explained: “All observations were specific to the nanotainers [blood specimen device] operating under the CLIA lab quality framework. The correction to the observations was to cut over to the FDA Quality Systems framework.” The solution is to draw a bright line between device operations and laboratory operations.

Laboratories will not be ready to become device manufacturers without a lot of work. The regulations are extensive have many differences, with more rigorous requirements, than the CLIA regulations. Compliance will be a major project for labs requiring planning, resources, and money.

This presentation provides practical information you need to understand the FDA’s intentions. It provides vital information a lab needs to prepare for the change. For example, the various timelines are confusing, but the webinar uses diagrams and simple explanations to clarify the issues.

In 90 minutes you will learn:

  • The need to notify FDA of all LDTs within six months
  • The new requirements for adverse event reports that apply to LDTs
  • The role of registration and listing, and the current fees
  • The requirements for premarket review, the timing, and fee issues
  • The structure of FDA’s schedule for premarket review
  • LDTs that FDA won’t regulate
  • Laboratory Directors and Managers
  • Laboratory Technical Supervisor
  • Quality Assurance Managers
  • Regulatory Affairs Managers
  • Program Managers

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.