Hope we can be fast tracked on the Lyme disease device. The vagus nerve full body device will require an IDE and PMA which are slow procesess. Lets hope Biel's history will let us get the IDE approved if it has not already been submitted and underway. "An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated."
https://www.fda.gov/medical-devices/premarket...mption-ide
$TILLABELIEVER$$
https://www.fda.gov/medical-devices/premarket...mption-ide
$TILLABELIEVER$$
