FDA eases UDI compliance requirements for some low-risk medical devices
The U.S. 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.
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.
FDA defines consumer health products as “510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores.”
The FDA guidance also identifies Class I devices that do not meet the agency’s definition of consumer health products. Although not exempt outright from GUDID submission requirements, these devices have been granted compliance deadline extension, to Dec. 8, 2022.
Article source: Medical Design Outsourcing