UDI regulation is here. Compliance is being staggered over seven years based on medical device classification from Class III (high risk) to Class 1 (low risk). Failure to follow the FDA’s UDI labeling and GUDID attribute guidelines could result in confiscation, injunction, and civil or criminal penalties. We can help.
What is UDI?
As part of the U.S. Food and Drug Administration’s implementation of the Federal Food, Drug and Cosmetic Act, the Unique Device Identifier (UDI) regulation requires manufacturers to adopt standardized labeling for all medical devices and to uniquely identify medical devices sold in the United States. Although patient safety is the main driver behind this regulation, UDI can be utilized within the healthcare supply chain from manufacturers all the way through to patient-facing healthcare providers.
We tailor our flexible, end-to-end compliance methodology to your company’s unique circumstances. The following chart shows our three-phase approach, which serves as a foundation and can easily be modified to meet your specific needs.
Three main actions are required for UDI compliance:
- Provide labeling for all medical devices to include a UDI in both human readable and Automatic Identification Data Capture (AIDC)/barcode format.
- Include device attributes in a Global Unique Device Identification Database (GUDID) to allow the healthcare community and the public to obtain critical information using the UDI Device Identifier as the key.
- Direct part marking (with UDI) on all medical devices that are reusable and require processing between patients in either human readable or AIDC/ barcode format.
Medical Device Classification and Key UDI Dates
The Cost Effective Solution to Complex Compliance
Compliance is one of RGP’s core competencies. Our accomplished professionals have 10-20 years’ experience in both consulting and corporate roles. We’ve helped thousands of clients navigate complex compliance initiatives, making the process as painless as possible. Let us help with your regulatory initiatives.