FDA Letter with extension of deadlines UDI

FDA issued a letter to Device Labelers on Sept. 6, 2016 extending the deadlines for UDI lablel and GUIDID submission requirements for certain Class II products and certain combination products to Sept. 14, 2018. The full letter details the specific device types is at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.