The Truth about Required Manufacturer Support for Discontinued Devices
March 10, 2021 | Evaluations & Guidance
Many clinical engineers believe that manufacturers are required by FDA to provide parts and service after a device has been discontinued for sale. It's not true. In fact, according to a recent emailed communication we had with FDA, manufacturers are not required to provide servicing, parts, or repairs for their products at any time—even when the device is first put on the market. Granted, successful firms with good business records will generally service their products for several years after discontinuation of new sales, but there is no requirement to do so.
In fact, manufacturers are not even required to notify their customers when they stop providing parts, stop providing service, or stop selling a device in the United States. Although some manufacturers issue "end of life" or "end of support" letters, they are not mandated to do so. FDA does ask manufacturers of discontinued devices to "delist" the device in FDA's Unified Registration and Listing System (FURLS), but manufacturers do not always take that action. Facilities may first hear about a product being discontinued when a...