Regulatory Open Forum

Hi,

Are there minimum font size requirements for the Direct Marking of devices for UDI?

We have some low profile tubes that will need to be laser etched, hence my question.

Thanks

The regulation does not specify any requirements other than what products are subject to Direct Marking. The FDA has a draft Direct Marking Guidance issued 26 June 2015 that provides additional information on DM.  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM452262.pdf 

Direct Marking is required only for devices that meet the following criteria:

• The device is intended to be used more than once
• The device is intended to be reprocessed before each use

Direct Marking needs to be included in your project's risk & human factors assessments as the DM needs to be readable/scannable. It will also need to be test & verified to ensure it is compliant with the Issuing Agency standards.

Keep in mind that if Direct Marking applies to the device, an exception can be made if any of the following apply:

• Any type of direct marking would interfere with the safety and effectiveness of the device
• It is not technologically feasible to directly mark the device
• The device is cleared/approved as a single use device
• The device already has a permanent UDI directly marked on the device