FDA UDI Requirements for In-Line Laser Marking

The serialization or marking of manufactured components has become essential to the highly regulated medical device industry. The FDA, and more recently the European Union, have imposed Unique Device Identification (UDI) requirements in order to improve medical device traceability. Not only does each device require a distinct label, but this UDI information also must be submitted to the appropriate UDI database and stored by the manufacturer. Component manufacturers such as Empire are adapting to meet these needs by investing in the technology necessary for in-line serialization.

Historically, serialization was completed as a separate process, after parts left the manufacturing floor and before final assembly or packaging. But regulatory compliance, cost of handling, and other factors today are making it more practical for component manufacturers to include this step in their own processes. Laser marking or laser engraving is of particular interest to the plastics industry, as it offers a range of solutions to address logging and data reporting requirements.

In-line laser marking of medical devices can simplify part tracking in several ways:

  • Inspection and approval of components prior to serialization reduces waste, paperwork, and cost.
  • Automatic entry of serialized components into the electronic tracking log saves time and prevents clerical errors, which can be costly during an FDA audit.
  • In-line marking avoids the added engineering and retooling costs of serializing through a redesign.


Download: Improving Cost & Performance in Medical Device Programs


Manufacturers providing serialization are often expected to provide full traceability for a manufactured part, extending over the part’s lifetime. Luckily, many laser marking systems today include sophisticated software control solutions for rapid, automated parts marking and encoding. To comply with regulatory marking requirements, the laser marking equipment is programmed to index through a sequence that gives each part a separate mark. When this occurs, the logging and reporting process generates an entry that may include date and time stamp, batch number, and other data collected for the individual part. This tracking information is then stored as data, on a local computer or processor, to be provided to the customer with the ordered parts as they ship as well as retained as a backup.

At Empire Precision Plastics, not only can we fabricate and mark plastic parts at high volumes with automated molding and laser marking processes, but we also have the ability to track and provide information on individual parts designed with laser marking information—even several years later. This value-added service has the potential to reduce cost and add design flexibility for customers, and it allows us to better serve customers as a supply chain partner. Contact us for more details.

Empire complies with all FDA identification and traceability standards. We also added clean room space for optical and medical molding and assembly as part of our latest expansion.