USA – FDA nixes GUDID submission requirements for class I consumer healthcare devices

Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.

Under the agency’s unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaining devices, will be subject to standard date formatting, UDI labeling, and GUDID data submission requirements no earlier than 24 September 2022. However, in the draft guidance, which will revise and supersede Section III of the compliance policy when finalized, FDA explains that it does not plan to enforce GUDID submission requirements for consumer healthcare products, though it still plans to enforce standard date formatting and UDI labeling requirements for such devices after 24 September 2022…