Prepare for medical device UDI labeling deadline 24 September 2016
From the 24th September 2016 the US Federal Drug Administration (FDA)requires unique device identifiers (UDI) to be included with labelling and packaging on all Class II medical devices and entered into the FDA’s Global Unique Device Identification Database (GUDID).
The example UDI label featured above contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, and details about the item.
To help manufacturers and suppliers of medical devices comply with the FDA regulation, industrial labelling manufacturer CILS has developed durable UDI labels which are printable using a standard laser or thermal transfer printer, ensuring clear, legible print with resistance to cleaning solvents, frequent handling, extreme temperatures (-180°C +388°C) etc.
UDI labels are available in any format, shape or size, and CILS are able to advise the best material and adhesive for your specific application.
Medical Device Compliance Requirements on September 24, 2016:
- “Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
- The labels and packages of class II medical devices must bear a UDI. 801.20.
- Dates on the labels of these devices must be formatted as required by § 801.18.
- Class II stand-alone software must provide its UDI as required by § 801.50(b).
- Data for class II devices that are required to be labelled with a UDI must be submitted to the GUDID database. 830.300.”