Overview Detailed Agenda Speaker Price/Registration
Course Agenda - Eastern Standard Time
Day One (9:00AM - 4:30PM)
9:00 – 9:30 AM: Registration 9:30 – 10:30 AM: The Law and Regulations
10:40 – 12:30 noon: Strategy and Planning
1:30 – 3:00 PM: Assembling the 510(k)
3:00 – 3:10AM: Break 3:10 – 4:30PM: Assembling the 510(k) (Continued)
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Day Two (8:30 AM - 12:30PM)
8:30 – 9:45 AM: FDA’s 510(k) Refuse to Accept
9:45 – 10:00 AM: Break 10:00 – 11:00 noon: The FDA Review Process
11:00 – 11:10 PM: Break 11:10 – 12:30 PM: 510(k) Post-Clearance Process
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