The FDA is expected to finalize its Unique Device Identification (UDI) regulation requirements before June of this year. While the medical device industry awaits these regulations, the Global Harmonization Task Force (GHTF) has gone ahead and released a draft guidance proposal for a UDI system that can be used worldwide.
The GHTF is a volunteer group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration) and the members of the medical device industry. Founded in 1992, the goal of the GHTF is the standardization of medical device regulation across the world.
The guidance proposal includes a requirement that all devices be tagged with a globally standardized tracking code that can be both scanned and read with the naked eye. In addition, manufacturers would be responsible for maintaining the “uniqueness of its UDI code for a medical device throughout all jurisdictions worldwide.”
The FDA’s UDI regulation is expected to follow the GHTF’s recommendation, and the FDA’s UDI database is under development – a prototype is expected to be ready at the end of 2011. The FDA will own and maintain the database, which will contain the static portion of unique device identifiers. Variable data, such as serial numbers and lot numbers, will not be included in the FDA’s database.
Those who need to comply with UDI should become familiar with the GHTF draft and provide feedback before April 30. To read the GHTF’s draft proposal for a global UDI system, click here.
Will you need to comply with the FDA’s UDI regulations? How will it affect you?