Recently, we asked the FDA for clarification on the adoption of technologies in regards to the application of the DPM on medical implants. The response was quite strong:
“According to the UDI rule (21 CFR 801.55), FDA is permitted, in certain circumstances, to grant to device labelers exceptions from or alternatives to UDI requirements. We note, however, such exceptions or alternatives would only apply to the regulatory provisions specified in the UDI rule itself. Importantly, the UDI rule does not restrict the size of the AIDC technology being used to convey the UDI. In fact, the preamble to the final rule explains that FDA’s intent was that the AIDC requirement be ‘technology neutral’ and notes that “…Requiring adherence to a particular AIDC technical standard would be detrimental to innovation concerning AIDC technologies, and would, we believe, do long-term harm by slowing the adoption of new technologies… FDA agrees with comments that recommend that FDA not require the use of specific forms of AIDC or specific AIDC technologies.” This means that as long as the device labeler was otherwise meeting the requirements of the UDI rule, there would be no reason to grant an exception from or alternative to a labeler for the AIDC technology being used to present the UDI.”
From what we can extrapolate, there appears to be the acknowledgement from the FDA UDI Helpdesk that if technology exists that facilitates for the marking and capture of the UDI, that this will not be a limiting factor to ensure the rapid expansion and adoption of UDI compliance. This seems to ensure that the technology will not have to wait on the bureaucracy for compliance.