According to the Hearing Industries Association (HIA), Washington, DC, the US Food and Drug Administration (FDA) published its final Unique Device Identification (UDI) rule in the Federal Register on September 24.
Under the new rule, the labels and packages of most medical devices will be required to carry a Unique Device Identifier (UDI) that features both plain text and automatic identification and data capture (AIDC) technology. A UDI is a unique numeric or alphanumeric code that provides certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device. This information will be contained in a publicly available UDI database. Hearing aids are covered by the regulations with varying requirements and compliance dates, depending on whether the hearing aids are regulated as Class I or Class II devices.
The rule goes into effect on December 23, although some provisions went into effect as early as October 24. FDA has released a draft guidance (in a PDF document) explaining its global UDI database, wherein every device manufacturer is required to submit the specific device identifiers for each of their marketed products. FDA has also adopted several industry recommendations in the final rule, including the elimination of a proposed requirement to directly mark implantable devices.
Generally, all devices—including Class I devices (ie, most hearing aids)—will need to comply with a device identifier requirement that specifies the version, model, and manufacturer of the device. Under the regulations, Class II and III devices are also required to include production identifier information, such as batch and lot numbers. Under the rule, the UDI must appear only on the device label and package in most cases, although certain limited types of devices will be required to have the UDI appear on the device itself.
The regulations establish implementation deadlines that vary from 2 to 7 years for Class I and II devices. FDA also clarified that devices already in inventory, and any finished device that is manufactured and labeled prior to the compliance date that applies to that device, are exempt from the UDI requirement. This exception expires 3 years after the compliance date established for the device.