News
August 21, 2008
Rosina Robinson to Chair Session and Present on the FDA Pre-IDE Process for Medical Devices
August 21, 2008, North Attleboro, MA - Early and systematic development of the optimal regulatory strategy can significantly reduce uncertainties in device development programs. For products whose regulatory requirements are unclear and where a clinical trial may be needed, a pre-IDE consultation with the US Food and Drug Administration could be a company's most meaningful investment. Utilized appropriately, the process provides a forum for substantive discussion with the agency that can make the difference between smooth sailing and a choppy ride.
Rosina Robinson, Principal Consultant, Regulatory Services, will chair and present "Pre-IDE Process: Optimizing Your Results" on September 16 at the 2008 RAPS Annual Conference & Exhibition in Boston, MA. With co-presenters Stephen P. Rhodes, Director, IDE and HDE Programs, CDRH/ODE and Elisa Harvey, D.V.M, Ph.D., Senior Regulatory Consultant, CardioMed Device Consultants, LLC, Ms. Robinson will discuss ways that medical device firms can take full advantage of the FDA pre-IDE process.
Speakers will not only offer suggestions on when and how to best utilize the pre-IDE process and share lists of "Do's and Don'ts" using real-life examples, but will present the FDA’s latest perspectives based on MDUFMA II and, if released in time, the FDA’s latest guidance document updating pre- meetings and submissions.
Visit www.raps.org for additional information.
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