The FDA introduced the unique device identifier system in 2013 to improve the tracking of medical devices from distribution to use. Since then, the agency has systematically established compliance dates for the healthcare industry to implement the new labeling requirements.
The agency sorts all medical devices or products into three classifications based on risk. Class I devices, like bandages, are low risk and subject to the least amount of regulatory controls. Class II devices, such as power wheelchairs, are deemed higher risk than Class I devices and require greater regulatory controls. Class III devices, like replacement heart valves, bring the most risk and are subject to the highest level of regulatory control.
The FDA places the responsibility for UDI compliance on the “labeler” of a medical device, or the owner of the brand. If the manufacturer does not sell the products under its own brand, it is not responsible for the UDI implementation.
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