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
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
Who Will Benefit?
Risk Management team members
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