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Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Why should you have attend While a few clinical laboratories have cleared their tests through 510(k), the assertion of jurisdiction over LDTs by FDA has not been welcomed by most clinical laboratories, and has yet to be tested in the courts. This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.

It will describe the current situation, which has FDA withdrawing their draft guidance, and Congress, in a 2013 law, calling for review of any new LDT guidance developed by FDA, prior to its issuance. Will FDA wait until this requirement sunsets in 2017? Presently, no new guidance appears to be on the books for 2014. Will FDA attempt to "get around" the requirement by issuing guidance under a different name? This talk will describe the reasons for FDAs concern, the legal arguments pro and con FDAs assertion of jurisdiction, the position of IVD manufacturers of competitive products, the situation today, and some possible outcomes.

These are the areas covered in this session

  • Definition of medical device, (21 USC 321(h))and how it has been interpreted by FDA and the courts
  • "Enforcement Discretion" and how it has been applied to LDT regulation
  • Extent of CLIA 88 authority over LDT performance
  • Role of US Congress in answering the question of FDA authority
  • International (EU) approach to LDTs

These areas of Experts will be benefited by this session

  • QA Specialist
  • Complaint Coordinator
  • Regulatory Specialist
  • QA Manager
  • QA Trainer
  • All above in Medical Device companies

Anna Longwell has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC.

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