Speaker Profile

Anna Longwell

Principal, Longwell and Associates

Anna Longwell is 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).



Speakers
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Medical Device Complaint Handling: MDR, Reports of Removals and Corrections

This presentation will step through the FDA regulations relating to post-market product problems, and give examples of how FDA currently interprets these regulations. Following this presentation, you should be able to decide whether your customer complaint requires not only investigation, but reporting to FDA, and in what format the report should be made, and to which section of the Agency.

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  •   Recorded
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Laboratory-Developed Tests: 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.

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