How do you obtain a 510(k) in today`s environment at FDA? And once you get it, how can you market a product with a general intended use statement when your product can be used in many patient populations? What to do when your things do not go right, how to answer Additional Information (AI) letters, when and how to push back, meeting with FDA and who to take and how to prepare, the appellate process at CDRH, what avenues to pursue and when.
When you get your 510(k) how to market your 510(k) , what communication strategy to adopt, what to do when FDA disagrees with your promotional positioning.
Proper understanding of 510(k) process from start to finish is mandatory to avoid problems along with understanding of promotional strategy is very much essential for all companies for success in this complex world of regulations.
The key is complete and proper training from experts who has worked on hunderds of 510(k)s, de novo submissions, PMAs and combination products.
Who Will Benefit? - Senior management
- Regulatory affairs
- Quality Assurance
- Risk Managers
- Risk Management team members
- Quality Engineering
- Market Research
- Clinical
- MDR Reporters
- Production
- Engineering & R&D
- Professionals involved with premarket notification to the FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices
- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
