The U.S. Food and Drug Administration (FDA) is establishing a Unique Device Identification (UDI) system to adequately identify and track devices through their distribution an use. When fully implemented, the devices themselves will include a UDI in human and machine-readable form. Compliance with this new rule is mandatory and any lack of compliance could not only mean steep fines and penalties but the loss of your company’s reputation. With 75 years of marking and engraving expertise, Gravotech can help navigate your company’s journey to FDA compliance.
In September 2013 the FDA released a rule which established a common worldwide system for product identification applied to all medical devices placed on the U.S. market. Device manufacturers must also submit certain information about each device to the FDA’s Global Unique Device Identification Database (GUDID). In collaboration with the National Library of Medicine, the FDA has created a portal called AccessGUDID to make device information available to everyone including patients, caregivers, hospitals, etc. The public can search and download information on specific models to ensure their loved ones are receiving the safest medical products available.
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