Customer Making Changes to a 510k Device They Purchased

[4810RAJ]

Hello Forum Members,

Does anyone have experience with the following situation?
A customer purchases capital equipment (class II) from a manufacturer. The manufacturer provides a maintenance contract if they want it. The customer knows there are design improvements that will reduce maintenance costs and improve reliability but the manufacturer is unwilling to implement the changes. The customer wants to make the changes themselves during the next maintenance cycle and document what they did. FYI the changes are very superficial and do not affect the intended use or fundamental technology of operation. What are the regulatory risks, if any?

Regards,

 

[Ronen E]

Hello and welcome to the Cove

In my opinion, if anyone but the manufacturer makes changes to a cleared device, they become regulatorily responsible. Even if the changes are supposedly "superficial" and wouldn't require a special 510(k), they'd have the burden of having all the background design information on record, and objectively establishing that the change IS insignificant in terms of device safety and effectiveness.

Cheers,
Ronen.