When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system. On 03 July 2012, the FDA released the proposed rule for UDIs.
The UDI is a code, similar in theory to a barcode, that will be printed on each device and will provide information about high-risk devices including the following:
- the device model
- the production information (such as a lot number)
- the serial number and expiration date of the device
- other unique attributes such as the size, shape, or software used in the device.
Information about the patients who use the device will remain private.
The UDIs will be deposited into a database (the Global Unique Device Identifier Database) that will be accessible to both the health care community and the public. The FDA says that the database will allow faster and more accurate analysis of adverse events (AEs), improve device recall efficiency, help to secure the device distribution chain, and reduce medical errors. Over-the-counter devices, class I devices that are exempt from GMP requirements, and other very low risk devices will be exempt from the UDI rule, but the FDA is seeking commentary on exemptions. It is estimated that it will cost $68 million per year over seven years to implement the system.
The FDA is accepting public comment on the rule for the next 120 days, and the rule will be finalized within 6 months after the comment period.
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