Class I & II Rx Medical Devices - Pre-Hospital Market Distribution questions

P

PDX-EMT

#1
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.
 
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Marc

Hunkered Down for the Duration with a Mask on...
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#3
Bump - Can anyone help with this? My Thanks in advance!
 
M

MIREGMGR

#4
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.
Generally it's not.

Note however that the FDA is responsible only for requiring device makers to label their products as to Rx-only or OTC status, and in the cast of Class II and III devices, to have that labeling be consistent with predicate device status, established risk profile, etc.

The FDA is not legally responsible for enforcing Rx-only marketing and sales rules/laws. Those are state responsibilities. In every state for which I have familiarity with the enforcement picture, there is no process for proactive review of device sales, and enforcement is totally dependent on receipt of complaints plus someone's workload plus probably other factors.

Note however that state regulatory structures and laws vary widely.

2) How does the above affect the device traceability requirements that a manufacturer has?
It doesn't. If a device maker needs to maintain traceability, so be it. You have to put an effective system in place, irrespective of the workings of the sales channels. In many instances, that will mean that your product will have very much more procedural constraint on its sales and marketing process, enforced contracturally by you, than what is minimally legally acceptable.
 
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