The restrictions related to the exemption from use of devices are described in 21 cfr xxx.9, where xxx refers to Parts 862-892. for Class III devices, a preliminary request for granting documents for wholesale sale (PMA), if only your gadget is not considered a device with preliminary modifications (which appeared on the market before the adoption of clarifications to medical equipment in 1976, a https://www.arksales.org/forum/discussion/medical-animation-portfolio-suggestions either by essence equivalent to such equipment and if: conditions pma have not {{been|turned into} presented.