Since Sept. 27, 2007, medical device manufacturers have been under pressure to adhere to a broad change to label compliance regulations in their industry. That was the date that President George Bush signed into law legislation that would require the creation of a unique device identification (UDI) database.
With oversight managed by the Food and Drug Administration (FDA), the UDI database will, conceptually, increase label tracking and traceability in the medical device manufacturing industry by requiring product makers to record unique identifiers on each device's label.
Better electronic reporting may improve medical safety, regulators theorize, since the FDA would be able to better track and identify counterfeit products. In addition, medical professionals would be able to better tell the difference between similar machines.
Developing this database is no small task. On its website, the FDA describes the various stages of the project's development – only some have been completed and most haven't even gotten off the ground.
That leaves some manufacturers unclear what their responsibilities might be during the process, and others unsure of what important deadlines they need to prepare for. To help, the FDA has provided a few informational workshops and conferences, the most recent of which will be held November 30 to December 1 at the Hyatt Regency in Cambridge, Massachusetts.
That conference – you can register at this link – will provide manufacturers with some actionable advice on how to plan for implementation, and allow them to receive an update on the FDA's latest actions.
The first step in complying with the UDI regulation is to plan for it. The second step? Finding a reliable provider of labeling solutions that can work with you throughout the transition process.