USA – FDA eases UDI compliance requirements for some low-risk medical devices

The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles.

GUDID exemptions for “consumer health products”

According to updated guidance from FDA on its UDI and Global Unique Device Identification Database (GUDID) policy for Class I and unclassified devices, the agency has exempted devices qualifying as consumer health products from GUDID submission requirements; however, these devices must still bear UDI data on their labeling and packaging…