powered by Pro Mach video

Pro Mach Web Site
ProCustomer Industry Leading Aftermarket Support
Allpax Retort Sterilization & Automation Systems
Axon Shrink & Stretch Sleeve Application Systems
Benchmark Food Distribution & Loading Systems
Brenton Case & Tray Packing & Robotic Systems
Currie by Brenton Conventional & Robotic Palletizing Systems
Dekka Case Taping Systems
Edson High Performance Case & Tray Packing Systems
EOL Packaging End of line Applications & Systems
EPI Labelers Flexible Packaging Labeling Systems
Federal Liquid Filling & Capping Systems
Flexible Packaging Flexible Packaging Applications & Systems
FLtecnics Rollstock Pouch Packaging Systems
Greydon Flexible Packaging Coding Systems
ID Technology Labeling, Marking & Coding Systems
Inever Stickpack & Sachet Packaging Systems
IPak Machinery Tray & Bliss Forming Systems
Jalbert Automation Services
KLEENLine Sanitary Product Handling Systems
LSI Pressure Sensitive Labeling Systems
Matrix Vertical Form Fill Seal Systems
NJM Packaging Pharmaceutical Packaging Systems
Orion Packaging Stretch & Pallet Wrapping Systems
Ossid Tray Packaging & Weighing Systems
Pace Packaging Bottle Unscrambling & Orienting Systems
Pacific Packaging Viscous Filling & Capping Systems
P.E. Labellers Decorative Labeling Systems
Rennco Vertical Bagging & Heat Sealing Systems
Roberts PolyPro Bottle & Box Handles & Application Systems
Shuttleworth Conveying & Material Handling Systems
Southern Packaging Rollstock Pouch Packaging Systems
Tekkra Shrink Bundling Systems
Texwrap Shrink Wrapping Systems
Toyo Jidoki Pre-Made Pouch Packaging Systems
Weiler Labeling Labeling & Serialization Systems
Wexxar/BEL Case Forming & Sealing Systems
Zalkin Americas Capping & Cap Handling Systems
Zalkin EMAA Capping & Cap Handling Systems
Zarpac Engineering & Integration Services

Powered by Pro Mach

FDA Publishes Proposed Rule for UDI System

Progress is being made in the U.S. Food and Drug Administration’s (FDA) UDI program. Ever since Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices, the FDA has been working closely with industry, the clinical community and patient and consumer groups, and has conducted four pilot studies.

Now the FDA has published proposed rules for the UDI system. Part of that proposal includes what the UDI labels will look like. UDI labels will include a picture, a barcode for tracking, and a description of the product. UDIs will also include a serial and batch number to assist tracing the product back to its place of origin and manufacturer. This information will make it easier to determine which company is responsible to the defective products. The figure depicts what a UDI label looks like for a fictitious medical device.

Example of what a universal device identifier (UDI) would look like on a medical device label.

The FDA’s current proposal requires UDI labeling on all product packaging and directly on implantable devices to make sure they can be identified. UDIs will also be applied on reusable products that are repeatedly sanitized and embedded in the microchips of electronic devices.

Once the FDA’s proposal is approved, the new labels will be phased in over several years. Class III medical devices, such as pacemakers, will require UDI labeling one year after the law goes into effect. The FDA will require class II devices, such as artificial knees, to add UDIs three years after the law is finalized.

You can find the complete published proposal here.

Share Button

Speak Your Mind