In the time since the FDA’s final rule on Unique Device Identification was published on Sept. 24, 2013, much of the process to create the system to identify medical devices marketed in the United States has proceeded as expected. However, there have been several notable developments.
Here are three things medical device manufacturers should know about the state of the UDI initiative today.
1. Some manufacturers can claim exemptions. Manufacturers of some Class II and Class I medical devices may be eligible for extensions or exemptions from the requirements of the final rule. It is recommended that all manufacturers review the FDA’s published guidance and answers to frequently asked questions to be sure they fully understand how the rule affects each product in their portfolios. For example, any Class I medical device that FDA has exempted from the good manufacturing practice requirements of 21 CFR 820 are also exempted entirely from UDI requirements. In some other cases, devices are exempted from the labeling requirements while still required to submit data to the GUDID. In addition to published general extensions and exceptions, some manufacturers have been granted individual extensions and exceptions based on specific requests submitted to the FDA on the Help Desk Inquiry Form.
2. GUDID is now public. Until recently, the Global Unique Device Identification Database has not been accessible to the public. In cooperation with the FDA, the National Library of Medicine last month launched AccessGUDID, a publicly accessible web tool, to search the database. This means that device manufacturers, other industry members, insurance companies, healthcare providers, and even patients can research devices and review the record of any device that has been published in the system.
3. International UDI compliance is here. Regulatory requirements are underway in Europe, Canada, China, and elsewhere. Medical device manufacturers that sell devices outside the U.S. or whose business plans include expansion into international markets will want to stay up to date on emerging rules around the world.