Replies to post #7380 on Grapefruit USA Inc (GPFT)

[goldcoastoh]

yes... keeping it simple, the process is a 510k (class 2) or PMA (class 3) when re: medical devices...

Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
If your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent.

Premarket Approval (PMA) - 21 CFR Part 814
Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm