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I have a series of questions regarding Class I and II Medical Devices.
The devices with which I am concerned are primarily of use in the prehospital market.
As follows:
1) I note there are several products classified as Rx (i.e. CombiTube, certain airway adjuncts, certain advanced hemostatics like QuikClot, etc..) that are sold through online distributors.
These products are all labelled RX only.
These distributors do not require a printed Rx in order to purchase. Although some do require a buyer to check a box that says that this product is being purchased "on the advise or direction of a physician..." or something to that effect.
These distributors are effectively selling Rx devices without an Rx. How is this legal?
This seems to be common practice and the FDA seems to not care.
2) How does the above affect the device traceability requirements that a manufacturer has?
3) When selling an Rx device through a distributor, what does the manufacturer of the device normally require the distributor to do in terms of ensuring Rx compliance and record-keeping. i.e. what is common contract language.
Any help or advice is appreciated.
The devices with which I am concerned are primarily of use in the prehospital market.
As follows:
1) I note there are several products classified as Rx (i.e. CombiTube, certain airway adjuncts, certain advanced hemostatics like QuikClot, etc..) that are sold through online distributors.
These products are all labelled RX only.
These distributors do not require a printed Rx in order to purchase. Although some do require a buyer to check a box that says that this product is being purchased "on the advise or direction of a physician..." or something to that effect.
These distributors are effectively selling Rx devices without an Rx. How is this legal?
This seems to be common practice and the FDA seems to not care.
2) How does the above affect the device traceability requirements that a manufacturer has?
3) When selling an Rx device through a distributor, what does the manufacturer of the device normally require the distributor to do in terms of ensuring Rx compliance and record-keeping. i.e. what is common contract language.
Any help or advice is appreciated.