510(k) Approval Timeline Part 2

My original 510(k) approval timeline is my post popular post ever!  I didn't even follow up with my latest project information.  We extended the disposable product line and it was 30 day FDA review, no questions asked / response required, approval in April to May 2010.  We justified not doing sterilization, biocompatibilty, shelf life, and packaging.  All in all it was about as good as it can get time wise.  Timeline went something like this:

• August to December 2009: Concept and prototype to design


• Jan to March 2010: Product build and verification / validation testing


• April to May 2010: 510(k) Approval

Our validation was an animal study using a physician, who filled out a questionnaire like one to ten, how much is this better than the predicate device after he or she used it, oh boy did I learn something there, I'll go over that some other time.



Now we just have to sell them...