MDDI -- In 2004, FDA published a final rule on bar code label requirements for drug and biological products. It subsequently began considering whether to expand that concept to medical device labeling. Over the past few years, FDA has held several meetings on unique device identification (UDI) to collect input from the device industry. It is expected that the agency will issue a draft guidance on the topic in the near future. The basis for these actions is FDA’s mandate to protect the consumer, in this case, patients. Evidence of significant medical errors related to product identification have made clear the need for regulatory initiatives.
