The phase-in of the Universal Device Identifier (UDI) program by the US FDA begins its second phase this September, marking a grey area for manufacturers of Class II medical devices. UDI labels allow manufacturers and regulatory bodies to effectively mark and identify medical devices through a globally harmonized system for improved traceability and patient safety. The United States introduced the law, which will be implemented over seven years, in 2013.
It is sometimes unclear, however, when and how medical and IVD device manufacturers should conform to UDI. Some large companies have been using the UDI system for years, but many smaller companies have not. Under new regulations, 510(k) applications submitted with non-UDI labelling may be delayed during the 510(k) review if the UDI due date for the device type becomes a requirement during the 510(k) review.
Manufacturers with Class II devices should ask three questions...