Unique Device Identifiers and the Challenge for the US FDA
This article was originally published in SRA
Regulatory affairs professionals from medical devices and diagnostics companies around the world are watching with interest as the US Food and Drug Administration contemplates and develops – as mandated by law – a draft regulation governing the use of unique device identifiers (UDIs) on medical products. The FDA’s draft notice of proposed rulemaking on UDIs is expected within the next 6-12 months. What the regulatory agency in the world’s largest single market determines on the matter will undoubtedly have an impact on how companies manufacture, package and sell products in the US and other markets that are considering similar UDI requirements.