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In Vitro Diagnostics – Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?

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Join Nerac Regulatory analysts Roz Sweeney, Ph.D. and Donna Mitchell-Magaldi for this powerful discussion designed to give you the insights and information you need on the new EU/FDA regulatory proposals/guidances and how they will be implemented by the agencies!!

It is imperative that IVD manufacturers prepare for upcoming/new regulatory changes in both the EU and US. CLIA labs in the US need to be ready for expected regulatory changes, with enforcement expected to begin around Q4, 2015.

EU Changes
In this portion of the webinar, we will discuss the most up to date (straight from RAPS Conference) information concerning the new EU classification system and what this means in terms of the amount of regulatory oversight for each, including:

  • Which IVDs will fall into which category?
  • When do auditors plan on implementing the system?
  • How much time will IVD companies have to comply?
  • What are the compliance requirements, such as product sampling, new clinical data requirements, unannounced audits and more!

FDA Changes
This portion of the webinar will cover the new draft guidance on laboratory developed tests (LDTs) for CLIA labs, including:

  • Timeframe for implementation by the agency
  • Which assays will likely be excluded from the law
  • Which assays will be considered high, medium, and low risk
  • New requirements for LDTs

Finally, we will discuss FDA guidance on assay migration studies and RUO/IUO assays.

Did you miss the webcast? You can listen and watch it here!

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