Unique Device Identifiers

The FDA is requiring that medical device makers place a Unique Device Identifier (UDI) on every product. And the deadline for compliance is approaching fast. 

• Do you know which deadlines will apply to your products? 
• Do you know if your suppliers are prepared for the rule? 
• Do you know what constitutes an FDA-compliant UDI? 
• Do you need to make changes to your manufacturing operations?

If you’re a medical device maker, it’s time you knew the answers to these questions now.

In 2012, the FDA proposed its long-planned, 165-page UDI rule. And now it’s hurry-up time for industry to come into compliance.

As with any rule, there are hundreds of details to be considered:

• Which classes of devices must be labeled with UDIs?
• What must be included in a UDI to satisfy the requirements
• What standards must be complied with for creating UDIs.
• How should you handle kits or small devices?
• What devices don’t need a UDI at all?

Buy now to immediately come up to speed on the new requirements of the proposed rule. This new report from FDAnews will take the anxiety out of the looming deadlines. It provides a clear, step-by-step explanation of the rule, covering:

• What’s required,
• When it’s required, and
• What parts of the rule FDA may still change

Don’t wait to find out how you’ll need to change your manufacturing systems or suppliers until it’s too late to avoid a delay in production. Get your roadmap to UDI compliance today.