Change is inevitable; Suffering is optional!!! This is the best way to describe the Medical Device User Fee Act III that, among other things, changes the way that the FDA accepts submissions for Medical Devices. This will cause significant changes in how Medical Device Companies need to handle 510(k) and PMA submissions between the years 2012-2017.
Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. As part of receiving such fees, the FDA makes commitments to the industry with regards to certain performance goals with regards to review and approval processes and timelines.
The Medical Device User Fee Amendments of 2012, or MDUFA III came into existence on October 1, 2012 and will sunset in five years on October 1, 2017. During that time, the processes for interacting with the FDA will be updated, impacting the way a medical device manufacturer does business with the FDA.
This webinar by speaker Angela Bazigos will review the changes the FDA is making in accepting Medical Device Submissions and will propose solutions to some of the problems that will result from those changes. The goal of the webinar is to reduce / eliminate suffering from these changes, by discussing the strategies required to move forward with minimal disruption to the business.
In addition, the session will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years. The new guidances that have resulted from “Refusal-to-Accept” and Electronic Submissions of Medical Device applications will also be presented, along with industry best practices or practices recommended by the FDA to assist the participants in efficiently adapting to the changes.
Who should attend? Clinical trial physician / doctor, manager to senior director of regulatory affairs, quality assurance, clinical research, data management, data monitoring, institutional review board, medical device companies e.g. Abbott, Stryker, medical device CROs for Clinical Studies e.g. Novella, Quintiles, clinical investigators e.g. Mayo Clinic, independent investigators, Institutional Review Boards e.g. Western (W IRB), data monitoring committees e.g. Westat, Wiley, Regulatory Affairs Professionals Society (RAPS), Society for Quality Assurance (SQA), American Society for Quality (ASQ), Association of Clinical Research Professionals (ACRP), American Medical Association, Society of Clinical Research Associates (SOCRA), Drug Information Association (DIA), regulatory affairs, quality assurance, clinical investigators, biostatisticians, institutional review boards and data monitors.
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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