The Pre-IDE Process…A Journey Not a Destination

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    Thursday 9:00-9:50 AM
    Abstract:

    The FDA initially introduced the pre-IDE process as a means of informal interaction to facilitate a clearer understanding of the agency’s expectations for the design of a medical device clinical trial or analytical testing prior to the submission of a formal Investigational Device Exemption (IDE).

    In recent years, the pre-IDE process has evolved into a valuable means for gaining FDA feedback in several other areas, most notably for non-significant risk, exempt or post-market studies which do not require an IDE, but will be used to support an eventual marketing submission.

    The FDA pre-IDE is a process that can provide medical device and diagnostics companies with a significant return on their investment, if time and resources are applied correctly. Workshop attendees will receive a step-by-step approach to planning, preparation, and execution. Attendees will also be provided a checklist of details for future reference.

    Faculty:

    Rosina Robinson, RN, M.Ed., RAC, Principal Consultant, Regulatory Services

    Rosina has over thirty years of experience in regulatory affairs and healthcare delivery. She has authored over fifty successful 510(k)s and many PMAs and PMA supplements for products representing a variety of medical specialties, with particular expertise in the regulation of cardiovascular, minimally invasive and general surgical devices. She guides clients through all types of premarket regulatory and clinical trial activities and is especially skilled at facilitating face-to-face communications between clients and the appropriate FDA center, including CDRH and CBER.

    Prior to joining MDCI in 1992, she was manager of clinical research and regulatory approvals at Haemonetics Corporation. Rosina is a member of the Regulatory Affairs Professionals Society, the Association of Operating Room Nurses, and the American Association of Blood Banks. She is a registered nurse, holds an M.Ed. from Bridgewater State College, and is Regulatory Affairs Certified. Rosina was also an adjunct professor in the Northeastern University Master of Science in Regulatory Affairs program from 2003 to 2007.
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    MDCI is a full-service regulatory consulting firm and CRO that has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for devices and diagnostic products in the U.S. and internationally.
    Specializing in the addressing the challenges around novel and innovative medical devices, in vitro diagnostics, and combination products, MDCI delivers customized strategies and “hands-on” solutions to meet regulatory, clinical trial, and quality assurance requirements at every stage of the product life cycle.

    Learn more about MDCI

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  • Conference Info:

     

    Date: June 26-27, 2013
    Location: The Metropolitan Club, New York City


    Audience: Institutional investors, high net worth individual investors, family offices, business development executives throughout the US and Europe building and financing high growth medical technology, health care and life science companies.

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