If you supply medical devices to the USA you must comply with the new US FDA UDI regulations.
Being able to identify, track and trace medical devices at a global level is important for patient safety. To help achieve this, the US FDA (Food and Drug Administration) has established a Unique Device Identification (UDI) system for medical devices in the US.
The FDA has mandated that suppliers and manufacturers of medical devices must comply with new regulations. These state that all medical devices entering the US healthcare supply chain must be identified with a UDI.
KEY US FDA UDI compliance dates
GS1 standards conform to all US FDA requirements.
What does the US FDA UDI regulation mean for you?
Any medical device manufacturer or supplier trading with the US healthcare market must comply with this regulation.
This mandate is phased over a 6 year period – and it started on 24 September 2014. You must check the FDA website to see which class or classes the products you supply fall under. Then you must check which compliance date or dates apply to the products you supply.
Using GS1 standards to enable compliance
GS1 has been accredited by the FDA as an issuing agency for UDIs and our standards for identification and barcoding conform to all FDA UDI requirements, including:
- Product identification at each level of the packaging hierarchy
- The barcode symbols to use
- The product data to be included in barcodes
- The data that must be stored within the Global UDI Database (GUDID) specified by the US FDA
Similar regulations to the FDA mandate are expected to follow globally, but adapting to these changes will be easy through GS1 standards – the industry benchmark in healthcare.
And using GS1 standards will not only help you comply but bring efficiency savings to the way you do business.
How GS1 Malaysia can help
As the experts on GS1 standards, we are ideally placed to help you comply with the FDA mandate, and ensure you will comply with EU requirements that will follow. Our range of training and implementation services is helping medical device manufacturers of all sizes to comply, but also operate more efficiently and save money.