FDA Class I UDI Submission Deadline

GUDID is the place to be for medical devices. Class I and Unclassified devices required to be labeled with a UDI code, must submit product data to US FDA GUDID by September 24, 2022.

Global Health Authorities

Unique Device Identification (UDI) Data Submission Compliance US FDA, EU EUDAMED, China NMPA, South Korea IMDIS and development of future health authority channels for activation. Learn more about SingleSource™ for Medical Devices

Health Canada Submissions

Gain insights into the forthcoming XML Product Monograph regulations and requirements for drug products in Canada.

Reed Tech Insights: EU Legacy Devices Series

In this series of 6 videos, Gary Saner, Sr Mgr Information Solutions at Reed Tech, does a deep dive into ‘What to Know’ concerning EU Legacy Devices for both MDR/IVDR, description, provisions, requirements and timelines.

Leverage Our Expertise in Life Sciences

LexisNexis Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

Medical Devices

%

~% of FDA GUDID Electronic Records Submitted Annually

Medical Device unique customers since inception

Records Submitted to FDA Global UDI Database

Pharmaceuticals

Years of Structured Product Labeling Experience

Pharmaceutical customers including manufacturers

Pharma FDA SPL submissions

What Our Customers Are Saying

“Reed Tech customer service is top-notch and very friendly, helpful and professional.”

-Regulatory Affairs & Compliance at an international provider of pharmaceutical, nutritional and veterinary products

What Our Customers Are Saying

“Excellent customer and technical support. Reed Tech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.”

– Regulatory Director at a premier provider of infection prevention and other procedural products and services

What Our Customers Are Saying

“Reed Tech has experts in Drug Listing and UDI and we can always count on them for their guidance for the best approach to be taken when needed.”

-Operations Head for a global medical device and pharmaceutical maker

What Our Customers Are Saying

The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us!

– Operations Manager at Regulatory Professionals Inc.

Medical Devices

Achieve UDI Submission with US FDA and Other Global Health Authorities

Build and submit UDI records electronically in Structured Product Labeling (SPL) format or seek subject-matter expertise.

Manage Medical Device Product Data for UDI & Syndication

Serving the medical device industry in the areas of compliance, data management and UDI regulatory requirements experience. 

Engagement Options for Managing UDI Product Data

Learn more about varied approaches to managing UDI product data.

Pharmaceuticals (Rx, OTC, and Biologics)

Simplify Drug Label Research with Quick Access to Targeted Label Information

Navigator™ for Drug Labels helps pharmaceutical regulatory researchers ensure accurate and up-to-date drug label content.

Structured Product Labeling Services for Rx, OTC and Biologics

Manage product listing, establishment facility, and labeler company data across multiple teams with a secure cloud-based solution.

Manage Regulated Drug Product Data in One Central Database

SingleSource™ for Drug Products manages FDA prescription, OTC and animal drug product submissions data in Structured Product Labeling (SPL) format.

Downloadable Product Information

Med Device Brochure

www.reedtech.com/udi

Pharma Brochure

www.reedtech.com/udi

Learn More About Regulatory Compliance and Product Data Management Solutions

Life Sciences Alliance

Learn More About

Schlafender Hase

www.reedtech.com/udi

Learn More About

Greenlight Guru

www.reedtech.com/spl

Alliance Resources

Virtual Events & Recordings

Recorded March 3, 2022

UDI Developments in Asia

Recorded February 22, 2022

New FDA Drug Distribution Report: What to know

Recorded February 1, 2022

Recorded January 27, 2022

Featured Blog Posts

European Union Flag

DIA Global Labeling Takeaways: Patient Materials and Health Literacy

May 19, 2022

European Union Flag

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

April 14, 2022

European Union Flag

LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

March 7, 2022

European Union Flag

Public Dashboard Now Available for REMS Data

March 7, 2022

European Union Flag

March 3, 2022

European Union Flag

How Can You Prepare for Unique Device Identification Product Data Submission in Asia?

March 1, 2022

Life Sciences Products

Medical Devices

Pharmaceuticals

Life Sciences In The News

Reed Tech Life SciencesJoin us for our OTC drug product monograph webinar series!

Register here for the next webinar in an ongoing series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues.

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