UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
Medical Device Regulatory Requirements – Japanese Guidelines
This is a quick summary of the December 14, 2022 Emergo Webinar presented by Kenji Yashiro on the topic: Medical...
Class I UDI Inventory Exception: What You Need to Know about FDA Compliance
In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without Unique Device Identification (UDI) as of the Compliance Date, commonly referred to as the 3-Year Inventory UDI Exception or the ‘Final Rule.’ Such devices meeting the criteria could be commercially distributed for 3 years after the corresponding Compliance Date without complying with UDI requirements. At the end of the 3-year period, any undistributed inventory would need to be reprocessed to comply with current UDI requirements, i.e., UDI Label and GUDID reporting.
Vision Expo West and Eyewear Industry UDI
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on...
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post
Status Update for Australia TGA UDI
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for...
FDA Class I Medical Device UDI Due December 2022
The Class I UDI data submissions to FDA GUDID has been updated to September 24, 2022, LexisNexis Reed Tech is here to help.
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device...
Preparing, Managing and Monitoring Medical Device UDI
In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda...
How Can You Prepare for Unique Device Identification Product Data Submission in Asia?
Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device...