US UDI deadlines near but medtech still none the wiser on exception criteria
This article was originally published in SRA
The US Food and Drug Administration has released information on how medical device labelers may request for an exception from, alternative to or more time to meet the impending requirements on unique device identification (UDI)1,2. However, the information fails to explain the criteria the agency will use to assess requests from companies as they work to meet the UDI compliance deadline, which starts to kick in on 24 September.
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