FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI).

Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last week.

In a letter to industry, FDA announced plans to push label, GUDID submission, and standard date format requirement dates to September 2020. Direct mark requirements will go into effect in September 2022. The agency also said it will release a guidance document regarding its enforcement decision, but wanted to inform industry as early as possible.

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