The FDA definitely isn't captured. The amount of fear and respect it commands in the industry is big even in the biggest medical device companies. I experienced

The FDA definitely isn't captured. The amount of fear and respect it commands in the industry is big even in the biggest medical device companies. I experienced how a competitor got shutdown, because they took a warning letter too lightly for another product in the same plant. The competitor lost more than 500m USD and never recovered in our market.