Distributing Replacement Parts for Class II Medical Devices

Not a replacement, but needs to replace the battery.
Hi Al, and Mark (sorry, got the threads mixed up)
Yes, basically you have it right. I was wrong off the bat with one part so perhaps this will help. The device is a wearable and needs to be replaced every 6 weeks or so. Currently, a pharmacy orders the replacement part (upon receipt of an RX from a Doc) and then distributes the new replacement product, upon arrival, to the consumer, like a pharmacy does with medication. Whether or not the battery needs to be replaced or if it is an RX product, are not really questions I am concerned with.

You laid it out very clearly, thank you.

The way I think of it: Anyone use a CPAP machine? For breathing at night? Well, its an RX product and you need replacement hoses and a replacement mask every once in a while. The company ships those mask and hose items directly to you. Do they need to be a pharmacy? What I'm learning is that we likely have to have a state-by-state strategy dealing with the state boards of pharmacy (or similar entities) to get approvals to ship these products...perhaps we need to become a pharmacy. Or we could just contract with a centralized pharmacy and sell our product to them.
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