Hi All!
Was curious if you could help lead me in the correct direction. Hypothetically speaking, I manufacture a Class II Medical Device and would like to know what it would take to ship replacement parts for this device, directly to the consumer. The replacement part would be a whole new device. Currently, the health care provider must write an RX for the device and then we must ship it to them and then they can give it to the patient. In this hypothetical world, we are talking about a device worn on the outside of the body which has a battery and the whole device itself needs to be swapped out every 6 weeks (the battery is not removable). Would appreciate it if you could let me know your level of expertise or background when answering. Thanks!
Was curious if you could help lead me in the correct direction. Hypothetically speaking, I manufacture a Class II Medical Device and would like to know what it would take to ship replacement parts for this device, directly to the consumer. The replacement part would be a whole new device. Currently, the health care provider must write an RX for the device and then we must ship it to them and then they can give it to the patient. In this hypothetical world, we are talking about a device worn on the outside of the body which has a battery and the whole device itself needs to be swapped out every 6 weeks (the battery is not removable). Would appreciate it if you could let me know your level of expertise or background when answering. Thanks!
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