FDA relaxes UDI requirements for certain low-risk medical devices
Steward Eisenhart, Emergo Group
The U.S. Food and Drug Administration has exempted low-risk medical devices considered consumer health products from certain unique device identification compliance requirements in accordance with the least burdensome principles.
According to the FDA’s updated guidance on its UDI and Global Unique Device Identification Database (GUDID) policy for Class I and unclassified devices, the agency has exempted devices qualified as consumer health products from the submission requirements GUDID; however, these devices must still carry UDI data on their labeling and packaging.
The FDA defines consumer health products as “510(k)-exempt Class I devices that are sold directly to consumers over the counter in physical stores and/or online.”
The FDA guidelines also identify Class I devices that do not meet the agency’s definition of consumer health products. While not entirely exempt from GUDID submission requirements, these devices have been granted an extension of the compliance deadline until December 8, 2022.
Read the whole story on the Emergo Group blog.
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