Unique Device Identifiers (UDIs) have been one of the hot topics in the Medical Device world in the last few years. The FDA requirements for UDIs became a reality last year with the first compliance date of September 24th, 2014 requiring the labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) to bear a UDI (§ 801.20). Dates on the labels of these devices had to be formatted as required by § 801.18. Data for these devices had to be submitted to the GUDID database (§ 830.300). Class III stand-alone software had to provide its UDI as required by § 801.50(b). (Editor’s note: See StarFish Analysis on class II device compliance 24 September 2016.)
Now the next UDI compliance date is fast approaching. What does that mean for your products and your company?
As of September 24th, 2015 the labels and packages of implantable, life-supporting, and life-sustaining devices must bear an UDI (§ 801.20). Dates on the labels of these devices must be formatted as required by 21CFR § 801.18. A device that is a life-supporting or life-sustaining device that is required to be labeled with an UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use (§ 801.45).
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b). Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with an UDI must be submitted to the GUDID database (§ 830.300).
The above requirements lead to a number of activities to ensure compliance. Below are some ideas of how these activities can be organised and successfully addressed:
- The first step is to get ready for UDI compliance by determining the scope of the project. This may include identifying the number and class of the affected devices, choosing a bar code standard and an accredited issuing agency.
- Next, an assessment step may include identification of sources for GUDID data, establishment of a process for data maintenance and determination how to apply UDI to all level of packaging.
- The last implementation step may include change of label design to accommodate the UDIs, implementation of new printers if needed, creating an interface between internal and external databases to allow for data submission and finally uploading data to GUDID per FDA deadlines.
The unique device identification system will be phased in over several years. You can find information about the next UDI compliance dates here. You can also find additional information about UDIs on the FDA website.
Image: GAO – www.gao.gov
Virginia Anastassova, RAC, is a Senior QA/RA Specialist at StarFish Medical. She brings extensive experience in quality management and regulatory affairs to our clients. Virginia is celebrating her second week at StarFish and her first blog