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Medical Device Manufacturers

Medical Device manufacturers are required to track certain devices throughout the supply chain

Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious health risks.

Device tracking ensures that manufacturers establish tracking systems that will enable them to promptly locate devices in commercial distribution.

InfiniTrak helps to establish a tracking system for tracking devices that under FDA regulations have track and trace requirements.

How InfiniTrak can help Medical Devices

InfiniTrak track & trace software tracks serial numbers through the supply chain. From medical device suppliers, through the manufacturers and distributors of medical devices, InfiniTrak protects your supply chain so that you know where your product is at all times.

With our team of experts, InfiniTrak can help you respond appropriately to recalls for specific products and defective components, taking the burden off of your business.

Do You Know the Unique Identifier Basics?

In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.

A UDI is a unique numeric or alphanumeric code that consists of two parts:

  1. a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
  2. a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
    • the lot or batch number within which a device was manufactured;
    • the serial number of a specific device;
    • the expiration date of a specific device;
    • the date a specific device was manufactured;
    • the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.

The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

InfiniTrak and new UDI Regulations

InfiniTrak supports UDI implementation by providing data mining services for business intelligence purposes, thereby allowing medical device manufacturers to expand quality control surveillance. InfiniTrak also tracks the performance of medical device suppliers to improve strategic sourcing practices.