There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.
The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:
- The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
- Dates on the labels of these devices must be formatted as required by § 801.18.
- Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
- A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
- Class III stand-alone software must provide its UDI as required by § 801.50(b).