FDA Announces More Enforcement Discretion for Direct Marking of UDIs on Medical Devices
The Food and Drug Administration updated its policy of enforcement discretion for certain unique device identifier requirements for medical devices. In a guidance document that supersedes an earlier one issued in January that delayed UDI requirements for class I and…
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unclassified devices (see 1801120017), FDA is adding new information on its compliance policy for devices that are manufactured before direct marking requirements apply but remain in inventory when those requirements take effect. For class III, LS/LS and class II devices, for which direct marking is already required, FDA will not enforce the requirements even after its three-year grace period if the device’s UDI can be derived from information directly marked on the device, such as catalog numbers, lot numbers or serial numbers. The same approach will apply to class I and unclassified devices once direct marking requirements for such devices take effect, FDA said.