On the other medical devices board
92545 January 15, 2017
Your information is somewhat correct. However, regulatory 'anything' is not found in any marketing 101 entry course or any curriculum in any undergrad or graduate program anywhere. Thus, it's twists and turns and timing are greatly misunderstood by most unfamiliar with the governmental processes.
They require extraordinary patience, determination and are expensive. Inane, shoot from the lip criticism, however, requires no intelligence, knowledge, experience, wisdom or financial horsepower whatsoever and is mostly ineffective gossip falling on deaf ears, taken very quickly and literally for what it is.
BIEL ActiPatch (it does work, the data set says so) FDA OTC USA . . . . . you know when