Maybe to late but FDA is looking to fast track so to say good proven devices?
FDA is seeking participation in the voluntary PMA CtQ pilot program starting from September 29, 2017. See the “Participation” section for instructions on how to submit a request to participate. This pilot program will run from September 29, 2017, to December 31, 2018. The voluntary PMA CtQ pilot program will accept the first nine participants with submissions that meet the acceptance criteria.
Sent Biel the info and we will see!