Vesna Janic

FDA Unique Device Identifier Rule

Companies that are selling medical devices in the US have to consider a new rule that was published by the FDA on July 2nd, 2012. The proposed rule requires a unique device identifier (UDI) in both plain text and machine readable format (i.e. bar code) placed on the label and packaging of marketed and sold medical devices.

UDI is based on the ISO 15459 standard; manufacturer creates Device Identifier (DI) (static information) consisting of manufacturer, make,model and Production Identifier (PI) (dynamic information) consisting of one or more of the following: serial, lot number, expiration and manufacturing date.

The FDA proposes a public Global Unique Device Identification Database (GUDID) that will store basic information for medical devices. UDIs will also be included in adverse event reports.

The implementation of the rule will be realized in stages over 7 years after adoption, starting with a mandatory date format for labels in the first year.

Manufacturers/labelers will need to:

  • Integrate the UDI into their existing information systems
  • Redesign their labels to include the UDI
  • Purchase, install and validate equipment to print and verify the UDI on labels
  • Assign a resource to submit and maintain information to the GUDID

This system should provide multiple benefits with the ultimate goal of improving safety, effectiveness and quality of medical devices. Standardized labels will allow rapid identification of a device, review and assessment of adverse events and in the case of a problem with a particular device – more effective recalls.

Example of what a universal device identifier (UDI) would look like on a medical device label. The label contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, details about the item, and an illustration of the item (source FDA website)

 

I highly recommend that you read the rule (Document ID: FDA-2011-N-0090-0001), but for a quick overview please see the FDA presentation on the subject.  If you have any concerns, you can send your comments to the FDA until Nov 7, 2012.

Vesna Janic is a Director of Quality/Regulatory at StarFish Medical.   She uses her expertise in quality systems and regulatory compliance to guide our QA/RA team and help clients avoid wasting time on their path to the market .



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