This 510K webinar will review the proposed changes currently being discussed regarding the 510K program and how these changes will likely impact the medical device industry in the future.
The 510K, one of the two primary pathways available to medical device manufacturers to bring new products to the market in the United States, has been the workhorse of the medical device industry for the past three decades.
But some say there is a “perfect storm” brewing: more product recalls being reported by the media, a new administration in Washington, D.C., and a newly appointed FDA commissioner who has said “there obviously have been some problems” at the Center for Devices and Radiological Health and has designated device reform as “a high priority” for the immediate future.In fact, this storm may have been developing for some time as former FDA Commissioner David Kessler described the device center as “dysfunctional” and “in meltdown.”
Will the 510K as it currently exists today remain the dominant pathway to get medical devices on to the market in the future? Only time will tell but attendees of this webinar will come away with a better understanding of the important issues being debated today and a greater insight on how to plan for the future.Areas Covered in the Webinar:
President , Vascular Sciences
Ph.D., is President of Vascular Sciences (www.vascularsci.com) in Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr.Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA).
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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