Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar 2013

Topics

• Minuses and pluses of pre-IDE meetings and how to approach them
• CDRH’s new proposals for the 510(k) program
• FDA’s "General/Specific Intended Use" guidance document
• When and how to appeal adverse 510(k) decisions: whether it is an NSE decision or an Additional Information letter
• Pre-clearance/pre-approval communications
• How FDA approaches the interpretation of it using real examples
• The promotional issues companies face post-approval

Who should Attend

• VPs, Directors and Heads of Regulatory Affairs
• CEOs &CFOs in medical device companies
• Senior and line Marketing and Sales Management
• VPs, Directors and Heads of Clinical Affairs
• Attorneys
• Regulatory Consultants
• Engineering & R&D
• Risk Managers
• R&D personnel involved in approving the design of medical devices
• Professionals involved with premarket notification to the FDA
• Medical device sales and marketing personnel