Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar 2013 is a seminar that covers topics such as:
- 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
Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar 2013 brings together:
- 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
