Bill Evans
Involved In Discussions
Our organization manufactures a low risk Class II bed that has electronics that raises and lowers the bed. When someone calls for a replacement component out of warranty, and the facility has hundreds of beds, the order is not associated with a device serial number. (think of going to an auto parts store and purchasing replacement shocks or brake pads there is no VIN number associated with the purchase)
What is the FDA guidance regarding selling replacement parts and traceability?
What is the FDA guidance regarding selling replacement parts and traceability?