FDA Announces Medical Device Tracking System

According to Reuters, the US Food and Drug Administration (FDA) announced last month that it would be requiring companies to include tracking codes on medical devices, allowing the agency to monitor them for safety issues or recalls.

According to the FDA, the tracking codes will be unique device identifier or UDI codes, which will be placed into a database that the agency will maintain, and will be publicly searchable.

“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used,” Dr. Jeffrey Shuren, director of the FDA’s medical device division said in a statement.

The agency said it plans to phase in the system by focusing on medical devices that carry the greatest risk of complications including pacemakers, defibrillators, heart pumps and artificial joints. Tracking numbers assigned to devices will include the product’s lot number, expiration date and manufacturing date. Devices will be separated into three categories, Class I to III, with Class III being the highest risk.

Manufacturers will be required to have records that will include all UDI codes through an accreditation process.

This is a welcome change; as of last week, the FDA had already issued 50 medical device recalls in 2013. A defective medical device can lead to serious complications causing death and catastrophic injuries.

If you or a loved one has been injured because of a dangerous drug or medical device, please contact our office immediately for a free consultation. We are available by calling toll free 888-841-9623. Our firm offers confidential, no obligation consultations.

Zoll & Kranz, LLC – Medical Drug and Device Attorneys

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