Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot
This webinar will discuss possible future actions by FDA and by the US laboratory community and assess their probability.This session will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests.
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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 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It will describe the current situation, which has FDA withdrawing their draft guidance, and Congress, in a 2013 law, calling for review of any new LDT guidance developed by FDA, prior to its issuance.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.
Areas Covered in the Session
Who Will Benefit:
- 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
- QA Specialist
- Complaint Coordinator
- Regulatory Specialist
- QA Manager
- QA Trainer
- All above in Medical Device companies
Anna Longwellis currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics.
They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.
Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She 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.
Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled "Due Diligence Points to Consider" in the "Expert's Guide to Healthcare Product Due Diligence" published by FDLI.
Ms. Longwell holds a bachelor's degree in Chemistry from San Francisco College for Women (now USF), a Master's degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).