EmiliaBedelia
Quite Involved in Discussions
Can a company claim compatibility with another company's devices, even if that other company specifically states NOT to use other company's devices with their products?
For the sake of example, let's say that my company makes electric toothbrushes consisting of a reusable powered brush motor and our own proprietary disposable brush heads. There are other companies that make the same types of devices. While there may be some slight differences in design, in general these devices are pretty much industry standard with the same dimensions/mode of operation, and they are relatively low risk. In theory, a customer could use another company's brush head with our motor and achieve a comparable performance.
Obviously the company would want customers to only buy their disposables - so the IFU might state "Only use accessories manufactured by Company X with the Company X Toothbrush Handle". However, if Company Y obtains the product from Company X and tests it, would they be able to clear their device for use with Company X's products (even if Company X restricts it in their labeling?) Would it be considered "off label" for them to state "Company Y brushheads can be used with Company X toothbrush handles" in direct contradiction to Company X's labeling?
I know this issue comes up with reprocessors/remanufacturers who "reverse engineer" specifications for sterile devices in order to clean/resterilize. Using the same logic, I suppose that if Company Y specifies certain performance specifications and verifies that the Company X/Company Y combination meets those specifications, FDA would find that acceptable?
Would the same logic hold for EU? For some reason I have the feeling that a notified body would care more about this (perhaps from a PMS/data perspective - I feel like they'd have an expectation that the company would have access to the data/information on the other company's product in order to claim interoperability) but this is only a gut reaction.
Thanks in advance for your feedback!
For the sake of example, let's say that my company makes electric toothbrushes consisting of a reusable powered brush motor and our own proprietary disposable brush heads. There are other companies that make the same types of devices. While there may be some slight differences in design, in general these devices are pretty much industry standard with the same dimensions/mode of operation, and they are relatively low risk. In theory, a customer could use another company's brush head with our motor and achieve a comparable performance.
Obviously the company would want customers to only buy their disposables - so the IFU might state "Only use accessories manufactured by Company X with the Company X Toothbrush Handle". However, if Company Y obtains the product from Company X and tests it, would they be able to clear their device for use with Company X's products (even if Company X restricts it in their labeling?) Would it be considered "off label" for them to state "Company Y brushheads can be used with Company X toothbrush handles" in direct contradiction to Company X's labeling?
I know this issue comes up with reprocessors/remanufacturers who "reverse engineer" specifications for sterile devices in order to clean/resterilize. Using the same logic, I suppose that if Company Y specifies certain performance specifications and verifies that the Company X/Company Y combination meets those specifications, FDA would find that acceptable?
Would the same logic hold for EU? For some reason I have the feeling that a notified body would care more about this (perhaps from a PMS/data perspective - I feel like they'd have an expectation that the company would have access to the data/information on the other company's product in order to claim interoperability) but this is only a gut reaction.
Thanks in advance for your feedback!
