Using RFID technology to meet FDA rule requirements

摘要

In 2013, the U.S. Food and Drug Administration (FDA) established a unique identification rule for medical devices.1 The FDA requires that medical device labels contain a unique device identifier (UDI) including a fixed device identifier with the device's labeler and version or model and variable production identifiers (e.g., lot number, serial number, expiration date, manufacture date). Some manufacturers have already adopted UDIs into their product labeling; as of September 24, 2016, all class II devices (e.g., implantable orthopedic devices) should comply with the UDI rule, with some exceptions for certain kits and repackaged items.1 The FDA classifies devices based on the risks associated with their use and regulation; class II devices are higher risk than class I and require more regulatory controls. Class II devices that require direct marking (i.e., devices intended to be used more than once and reprocessed before each use) and class I devices (e.g., oxygen masks) do not need to comply with the UDI rule until 2018.