Know Your Device Classification:
Your device falls into one of three classes of medical devices defined by the FDA. Each class of device has a different a) deadline for UDI implementation and b) type of UDI labelling that must be done. Device classes are determined by the level of risk associated with each device – the higher the class, the worse it would be if the device didn’t do its job.
Class I Devices: Lowest risk devices, like floss, gauze, and bandages.
Class II Devices: Moderate risk devices, like syringes.
Class III Devices: Highest risk devices, like implantable devices such as pacemakers.
Implantable, Life-Supporting, and Life-Sustaining Devices: Highest risk devices classified by the FDA for this category.
1. If you are uncertain of the classification of your device, visit the FDA’s Product Classification Database, where you can search by device name or device panel (medical specialty) to which your device belongs.
FDA Product Classification Database: Link
2. Know the UDI Deadline for Your Device
You must submit your medical device identifiers (the “DI” part of a UDI) to the FDA and incorporate your UDI (codes and proper format) into your medical device labels no later than:
Class III Devices: 24 September 2014
Implantable, Life-Supporting ad Life-Sustaining Devices: 24 September 2015
Class II Devices: 24 September 2016
Class I Devices: 24 September 2018
For a complete timeline and details, be sure to read the FDA’s Compliance Dates for UDI Requirements.
FDA Compliance Dates for UDI Requirements: Link
3. Know the UDI Requirements for Your Device
The labelling standards for each medical device may vary across product lines, manufacturer sites, and business units. Depending on these factors, you may be required to implement a number of different UDI labels that each require their own unique format, content, and data. Even different levels of medical device packaging require distinct UDI codes and labels. Your issuing agency (the organization that assigns UDIs according to the FDA rule – either GS1, HIBCC, or ICCBBA-ISBT 128) can outline what your UDI will need based on your operations, device types, or device batching procedures.
Keep in mind that previous labeling processes may not be compliant to the new UDI guidelines. Make sure to verify your device labels for 100% compliance to your unique UDI requirements to avoid production waste, and costly compliance errors found during your manufacturing process that may result in fines and legal action if mislabeled product is released to the market.
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FDA Clasification UDI-Video