April 14, 2018

Tips for FDA Green Light on UDI Labeling

UDI labeling is entering the FDA spotlight. The point of Unique Device Identification is to ensure your product travels and is trackable from dock to the clinical environment.  The key labeling elements include reference numbers, product descriptions, expiration dates, quantities, and identifiers.  Health care professionals rely on all of this information to properly use, store, and locate devices. More importantly, regulatory leaders are increasing labeling scrutiny.

Avoiding the risk of smudged or damaged labels can be as simple as employing proper material testing methods.  Sutherland Rub testing is a cost effective step to assess your current materials and process, with the opportunity to consider other material or technology options if risks are found.

The medical labeling industry is currently undergoing new FDA requirement plans.  Unique Device Identification is in the implementation phase. In fact, it is projected that all devices will require both computer- and human-readable labels by 2020.  These labels will include reference, lot, and expiration dates in certain formats.

There are four steps for successful UDI implementation:

  • Identify all sealable SKU’s/ configurations, then obtain “UDI’s” for each. FDA-accredited issuing agencies include GS1, HIBCC, and ICCBBA.
  • Add the UDI to product labeling necessary elements are the “Device Identifier” (DI) obtained in the step above + “Production Identifier” (PI) which is usually the lot/expiration date. This information must appear as a barcode (1-D or 2-D are both acceptable) along with the human-readable text.
  • Register with the FDA’s Global UDI Database (GUDID). This is a publicly searchable repository.
  • Implement UDI rollout according to established FDA timelines

Taking a straightforward look at your current protocol, understanding where FDA priorities are headed and getting ready now will save money, time and headaches later when the deadline causes a rush to the finish for procrastinators. Labeling compliance and quality are straightforward issues to tackle. PCL can help you gain FDA approval efficiently and inexpensively.