Grapefruit USA Inc (GPFT)

[AOK11]

It looks like there may be more waiting involved. Unfortunately our 501(k) was one of the rare cases that require an IDE prior to being approved for the market. But at least we may be seeing some new images soon.

Investigational Device Exemption (IDE) - An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data
required to support a Premarket Approval (PMA) application and in some rare situations a Premarket Notification (510(k)) submission. Only a small percentage of 510(k)s require clinical data to support a marketing clearance by the Food and Drug Administration (FDA). An IDE limits the distribution of an investigational device only to the sites identified in the IDE application. In addition to FDA requirements, clinical studies of devices are also monitored by Institutional Review Boards (IRB) located at hospitals or other facilities where the clinical studies are conducted. An IRB, is composed of medical experts and lay persons.