FDA Creates New Code-Based System For Identifying Medical Devices


With numerous problems being discovered with medical devices today, including those that led to the massive Stryker® Hip Recall, the U.S Food and Drug Administration (FDA) has announced they will be launching a new program to address these issues. Officials say the new program will help to identify problems with medical devices faster, thus improving patient safety.

According to a press release from the agency, the new program will create a system that will consist of giving every new regulated medical device a Unique Device Identification (UDI) code. These codes will consist of a bar code that can be scanned that is made up of a series of numbers and letters that are individual to that specific device.

Experts say there will be two parts to the new codes. The first section will consist of information regarding the maker and type of device the unit being marked is. The second section of code will be made up of data indicating each unit’s:

  • Batch and Lot Number
  • Serial Number
  • Expiration Date
  • Manufacture Data
  • Identification Codes for Organic Devices

A similar system has been designed for use in devices that are used worldwide and will be implemented in the near future.

The Daniels Law Firm, P.C. is a North Carolina law firm practicing in complex litigation including class actions, products liability, business and securities litigation, environmental litigation and mass torts litigation of defective medical devices and pharmaceutical drugs. The Daniels Law Firm has an extensive practice in consumer litigation, personal injury law and wrongful death cases. Additional information is available at www.danielslawfirm.net.

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