08/25/2022
After reading all 70 pages and pondering on it for a few days and bouncing ideas and listening to others, one thing is very evident. If you think you will make it through this application process (even with a revamp of some type) and you don't have an EXTREMELY strong marketing plan, you're sorely mistaken.
We encourage all manufacturers to join the only Industry Network having regular meetings with the FDA.
Some people out there think they may have the answer, but unless you're spending 7 figures on a distribution network with post market surveillance, this is an insurmountable hill.
Join the Responsible Industry Network now, prices will inevitably go up, but SFATA always grandfathers existing members.
SFATA.org
https://media.ca11.uscourts.gov/opinions/pub/files/202113340.pdf