Question of the Month with Comment
MedSun: Newsletter #5, June 2006

Question:
We are having difficulty getting parts for a discontinued device. Is the original equipment manufacturer (OEM) required by law to provide service parts for 7 years from the date of last manufacture?

Comment:
There is no requirement under FDA regulations for an OEM to continue to provide service parts or service for devices once they are in the consignee’s (customer’s) possession. Issues of service and parts should be addressed in the contract for the purchase and sale of the product. A requirement to provide service and parts is a contract issue, not a regulatory issue.


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