and has just spent the last 45 days putting together action plans and implementation schedules for compliance and an on-site audit response, I can assure you that not ALL companies in the Medical Device industry are dictating ANYTHING to the FDA...

Sleazy sales reps and greedy executives not withstanding, there are millions of actual hard working people involved in the industry, much as there are in oil-gas and automotive industries. There's no doubt that drug safety is a vitally important thing for our society and individual health, but the problem is the same as it is in other industries...too often the reprobates and low-life directors are the ones rigging the system to a very narrow benefit.