FDA Class I UDI Submissions

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 (due September 24, extended to December 8, 2022). Contact Reed Tech for experienced help with UDI.

Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format & Additional Pharma Annual Deadlines

Review the annual deadlines that pharmaceutical companies are required to fulfill to become and remain compliant with the US Food and Drug Administration (FDA), with a special focus on the new REMS in SPL deadline.

Global Health Authorities

Unique Device Identification (UDI) Data Submission Compliance to 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.

Leverage Our Expertise in Life Sciences

LexisNexis Reed Tech enables innovators to accomplish more by helping them understand the nuances of regulatory requirements, create product data management strategies and meet compliance deadlines on time.

Our customers create life-changing innovations, we help solve their complex regulatory challenges.

Medical Devices


~% of FDA GUDID Electronic Records Submitted Annually

Medical Device unique customers since inception

Records Submitted to FDA Global UDI Database


Years of Structured Product Labeling Experience

Pharmaceutical customers including manufacturers


Pharma FDA SPL submissions delivered within contracted time

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 for all Global Health Authorities

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

Meet UDI Regulatory Data Submission Timelines 

Active channels include US FDA, China NMPA, South Korea MFDS, EU EUDAMED and other emerging regions.

Our Core Business is 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.

Solutions & Services

Med Device Brochure


Pharma Brochure


Learn More About Regulatory Compliance and Product Data Management Solutions

Life Sciences Alliance

Learn More About

Schlafender Hase


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Greenlight Guru


Official UDI Provider

Virtual Events & Recordings

Understand the Updates: FDA Drug Distribution Report

Recorded March 23, 2022

Recorded March 3, 2022

UDI Developments in Asia

Recorded February 22, 2022

New FDA Drug Distribution Report: What to know

Recorded February 1, 2022

Featured Blog Posts


MoCRA: The Future of Cosmetic Regulations

January 24, 2023


EU Proposal to Extend Legacy Medical Device Transition

January 5, 2023


US FDA Class I Inventory Exception

November 14, 2022

Ultimate Guide to UDI for Medical Devices

August 15, 2022

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

Life Sciences Products

Medical Devices


Life Sciences In The News