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
Past Events
Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar 2013 - 14-15 Mar 2013, Sheraton San Diego Resort, California, United States (37070)
Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar 2026
Important
Please, check "Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar" official website for possible changes, before making any traveling arrangements
