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

Finally, FDA Proposes UDI Ruling

The Food and Drug Administration (FDA) has released a proposed rule mandating that most medical devices distributed in the United States carry a unique device identifier, or UDI.

Back in 2007, Congress passed legislation requiring the FDA to develop regulations to establish a unique device identification system for medical devices. The UDI system can help the FDA find problems with medical devices much earlier, track recalls more efficiently, and improve patient safety. Since that time, the FDA has been working with medical device manufacturers, industry experts, and patient and consumer groups, conducting pilot studies and gathering information to create the proposed rule. To minimize industry costs and speed implementation, the proposed rule builds upon current standards and systems already in use by some companies.

The UDI would include a unique device identifier code specific to a device model, and a product identifier that includes current production information for that device. UDI information will be stored in a publicly available UDI database. Over-the-counter devices sold at retail stores would be exempt from the FDA rule, since these types of items have a UPC code in place.

The UDI system provides important benefits including reducing medical errors, rapid identification and tracking of defective medical devices, and more useful electronic patient records.

The FDA is seeking comment on the proposal for 120 days. A final rule would become effective in stages, over a period of seven years. For more information, and details on how to comment on the proposed ruling, read Proposed Rule: Unique Device Identification System.

Share Button


  1. The location of the PDF file for the proposed rule seemed to have been moved. I changed the link to go to the new location.

Speak Your Mind