Re: Likelihood of approval by the FDA in medical device
1. I would like to not believe that statistic, because RTA is easy. it does require attention to detail, but FDA makes it easy if you are awake to get through RTA.
I have yet to have a problem with RTA; I know of one person who failed it but he has dyslexia.
RTA just means that you included the various items, such as a biocompatibility report. it doesn't mean that the included items are any good. for instance, if biocompatibility is supposed to test the patient contact surface and upon reading the report it is clear that device component was not tested, you will not get clearance.
2. Business people generally do not approve of any kind of regulation. I hear this kind of statement often; it means that the company has not figured out how to be successful in the medical device industry and it needs someone to blame. the FDA is a convenient target. recent example: upon failing to log in to an FDA database due to using an incorrect password, the response was "@#!%# FDA" followed by going home early in frustration. Business will take the easiest path; for a given product, if the MDD is easier than QSR it will be Europe. If QSR is easier than MDD, it will be USA.