On September 6, 2016, FDA-CDRH issued a letter to device labelers extending the compliance date for UDI label and GUDID submission requirements, in some specific cases, to September 24, 2018. The letter is available at http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
There are three cases covered by the letter.
For two or more different devices packaged together, 801.30(a)(11) allows an exemption to including a UDI on the devices inside as long as the label carries a UDI for the package. FDA issued draft guidance document explaining when this exemptions applies and when it does not. The extension allows FDA to time to issue the final guidance.
For two or more of the same single use devices packaged together, 801.30(a)(3) allows an exemption to including the a UDI on the devices inside as long as the label carries a UDI for the package. The extension applies to repackagers, i.e., a firm that packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
For co-packaged or cross-labeled combination products, 801.30(a)(11) allows an exemption to including a UDI on the device constituent as long as the package label carries a UDI. The extension applies to combination products assigned to Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for premarket review and regulation.
For specific details in all three cases, refer to the letter.