FDA's medical device ID proposal: Big news for laser marking firms

Washington, DC -- Attention all industrial laser marking system suppliers and all laser marking job shops: if you haven't seen this, you'd better read it. Looks like a potential pot-of-gold at the end of the marking rainbow.

The US Food and Drug Administration has issued a proposal for a unique device identifier (UDI) on most medical devices distributed in the US.

A UDI is defined as a unique numeric or alphanumeric code specific to a device model, acting as a key to identifying device information: name of manufacturer, type of device, its expiration date, batch and lot number, etc. The information would be kept in a public database, with no identifying patient information.

Such a UDI system is expected to help the FDA with medical device adverse events reports, helping identify product problems more quickly, better target recalls, and above all improve patient safety. The FDA, industry, clinical community, and patient and consumer groups have all worked closely in conducting four pilot studies backing the proposed rule. The FDA is seeking comment for 120 days.

"The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety," said FDA Commissioner Margaret A. Hamburg, M.D.

Under the proposed rule (with certain exceptions), a UDI would include:

• A device identifier -- a unique numeric or alphanumeric code specific to a device model
• A production identifier -- which includes the current production information for a device

The FDA proposes a risk-based, phase-in approach to implementation, focusing first on highest-risk medical devices and exempting low-risk ones (such as over-the-counter devices which generally have UPC codes) from some or all of the requirements.

More information on the proposed rule is available on the FDA's Web site, downloadable as a 165-page PDF.