FDA has released the long-awaited proposed final rule for implementation of the unique device identification (UDI) regulation passed by Congress in 2007. The initial 60-day comment period began on July 10, 2012. FDA has extended the comment period until October 25, 2012. Quoted from the Federal Register, Volume 77, Issue 180, “The Agency has received requests for a 45-day extension of the comment period for the information collection. Each request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the information collection.” The proposed rule can be found and comments provided to FDA here.
The proposed rule further states, “Under the proposed system, the health care community and the public would be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will provide a key to obtain critical information from a new database, the Global Unique Device Identification Database (GUDID), which will include information important to the identification of devices.” UDI is based on automatic identification and data capture (AIDC) technology and will follow established international technical standards. The standards are included in the proposed new 21 CFR Part 830, Unique Device Identification.
So what is UDI? Simply stated, on the FDA website, “A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.”
And lastly, why this posting asks are you ready? The proposed revision of 21 CFR Part 801 – Labeling, has the following information on the effectiveness of when UDI must be on devices after the publication date of the final rule:
- Class III medical device or a device licensed under the Public Health Service Act – 1 Year
- Class II – 3 Years
- Class I and devices not classified – 5 Years
The bottom line – FDA has issued a proposed final rule and is expecting industry to be ready to comply with the regulation once it is final.