The FDA is distributing a draft guidance document on UDI Direct Marking of Devices and is asking for comments and suggestions within 90 of publication in the Federal Register.
The FDA’s Final rule on Unique Device Identification (UDI), which was passed on September 24, 2013, mandates a system of identifying medical devices for the purpose of tracking them to ensure quicker recalls and improve patient safety.
The UDI system consists of two items. One item is a unique device identifier that includes identifying information like the device’s lot or batch number, expiration data, and manufacturing date. The other item is a publicly searchable database called the Global Unique Device Identification Database (GUDID) that serves as a reference catalogue for every device with an identifier.
The purpose of the draft document is to assist medical device manufacturers in understanding FDA requirements for UID direct marking of devices. As defined in the Title 21 of the Code of Federal Regulations, “[a]device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”
As explained in the preamble of the UDI Rule, direct marking requirements apply to devices that are intended to be used for months or years. Since such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages. Direct marking helps to ensure the adequate identification of such devices through their distribution and useful life.
The FDA does not specify a particular direct marking method, but can include etching, attaching a permanent plaque to durable equipment, or affixing a permanent tag, such as an RFID tag. It is left to the labeler of medical devices to decide the appropriate method of permanently marking devices. Using a laser system for direct part marking is often an ideal solution.
For more information about the FDA’s draft guidance on UDI direct marking of devices, you can access the document here.
Compliance dates for direct part marking on life-sustaining and life-supporting devices is September 24, 2015. Are you ready? We have a variety of technologies for direct marking that will comply with FDA mandates. Give us a call at 888-438-3242 Option#3 or contact David Holliday directly at firstname.lastname@example.org.