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 Releases UDI Small Entity Compliance Guide

UDI Guide Cover On August 13, 2014, the FDA released a guide to the UDI rule called “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff.”

This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September 24, 2013, final rule establishing a unique device identification system; see 78 FR 58786 et seq. It provides an overview of the UDI Rule’s regulatory requirements and discusses the actions a small entity should take to meet those requirements. Other guidance documents, such as the guidance document titled Global Unique Device Identification Database (GUDID) and issued on June 25, 2014, discuss in greater detail the technical implementation of the UDI Rule. (- page 4.)

The FDA published a final rule on September 24, 2013, establishing a unique device identification system (the UDI Rule). Some parts of the rule became effective on October 24, 2013. The remaining parts became effective on December 13, 2013. Certain requirements within the rule have later compliance dates. Companies who must meet the UDI final rule, including makers of class III medical devices, must comply by September 24, 2014.

Download your copy of  the FDA’s Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff: August 13, 2014. (PDF – 518KB)

UDI Compliance With ID Technology

150UDIebookFor more information about the UDI ruling and how to simply compliance, please download UDI Ebook from ID Technology. ID Technology will help you comply with the FDA’s Unique Identification (UDI) labeling, marking and automatic ID requirements. Please contact us here or call (888) 438-3242.

 

Share Button

Speak Your Mind

*