The new draft literally doesn't change anything. It just defines some of the things that FDA has been already asking for in the past 7 years for every device submission.
Just my opinion as someone who has worked on many infusion pumps; that FDA review division is the best at FDA. They probably ask more cybersecurity questions than any other group I've encountered.
Just my opinion as someone who has worked on many infusion pumps; that FDA review division is the best at FDA. They probably ask more cybersecurity questions than any other group I've encountered.
I review a minimum of 5x - 510ks a week.