Off the Shelf Parts - Serial to USB adapter for a Medical Device

[Silvertabb]

Hi
We have a medical device which connects to client PC via serial connection. Technology has evolved. Most PCs now have USB connection only so as a result some accounts will need a Serial to USB adapter.

If we buy off the shelf serial to USB adapters from local electronic store/distributor, perform the verification to show the part works for intended use, and assign it a separate SKU, what additional Regulatory requirements need to be fulfilled for US FDA? Will this USB adapter be a medical device even though it is sent to customers separately.

 

[Wes Bucey]

Re: Off the Shelf Parts

Hi
We have a medical device which connects to client PC via serial connection. Technology has evolved. Most PCs now have USB connection only so as a result some accounts will need a Serial to USB adapter.

If we buy off the shelf serial to USB adapters from local electronic store/distributor, perform the verification to show the part works for intended use, and assign it a separate SKU, what additional Regulatory requirements need to be fulfilled for US FDA? Will this USB adapter be a medical device even though it is sent to customers separately.

If you are currently registered to FDA and/or ISO13485, it is a straightforward question you can ask the FDA and the Registrar.

From my point of view, I might also consider whether ONLY the adapter you choose to buy and ship to a customer is allowed or whether the customer could supply his own adapter of any other brand. I imagine you don't restrict which brand of PC is acceptable, although you might specify minimum features, operating systems, etc. for the PC.

Is there a change in the works to ship a USB adapter with all future systems? Will the product be revised to eliminate serial connection and use only USB? Future plans for wireless with a dongle?

As I see it the issue is not once and done, but how your organization intends to move forward with this product to accommodate changes in user-provided equipment and still comply with FDA and ISO13485.

All of this, of course, fits broadly under the umbrella of Configuration Management.