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Status Update for Australia TGA UDI

Status Update for Australia TGA UDI

The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance   News of note: • TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model• A...

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FDA Class I Medical Device UDI Due December 2022

FDA Class I Medical Device UDI Due December 2022

Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI)...

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UDI Conferences In-Person September 2022

UDI Conferences In-Person September 2022

We are excited to be returning to 'in-person' conferences this September. Look for us at  RAPS Convergence 2022 on September 11-13. RAPS Panel Session: EUDAMED & UDI – Evolution of the EU Regulatory Landscape on Tuesday, September 13, 2022 | 4:35 PM – 5:30 PM MST...

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What’s Been Happening with Health Canada XML PM Mandates?

What’s Been Happening with Health Canada XML PM Mandates?

Reed Tech recently presented a webinar to update customers with the most recent information about XML product monograph (XML PM) and how to best navigate them. In the webinar, Gary Saner, Sr. Manager, Information Sciences, discusses the history of Health Canada...

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Preparing, Managing and Monitoring Medical Device UDI

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 specializes in helping medical device manufacturers with Unique Device Identification solutions for global health authorities like US FDA, EUDAMED and...

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Public Dashboard Now Available for REMS Data

Public Dashboard Now Available for REMS Data

A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs with approved Risk Evaluation and Mitigation Strategy (REMS.) According to FDA, This new dashboard includes visualizations and charts for total and...

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Is My Product a Medical Device?

Is My Product a Medical Device?

A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’. Intended Use and Indications for Use are key determiners and FDA provides clear guidance. Packaging and accessory definitions can be reasons for...

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What is a UDI label and UDI requirements?

What is a UDI label and UDI requirements?

What is UDI?Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI).  UDI is specific to a device model and version of that device on the market.How Do You Create the UDI?The...

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FDA Withdraws 216 ANDAs

FDA Withdraws 216 ANDAs

Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines including blanket no-change certification (BNCC) or establishment registration (ER). Due to non-compliance with these annual...

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Overview of Pharma Annual Deadlines and Requirements

Overview of Pharma Annual Deadlines and Requirements

Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to numerous guidances and mandates to develop and maintain compliance with the FDA. Though every company is different and each situation is unique, the...

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FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID? It is a database that contains key device information submitted to the FDA, including Unique Device Identifier (UDI) product data. Within the FDA...

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New Drug Application (NDA): Back to the Basics

New Drug Application (NDA): Back to the Basics

What is a New Drug Application (NDA)?Every new drug in the United States needs to come to market through a New Drug Application with the FDA. According to the FDA, “The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a...

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Customer Q&A: OMUFA Update

Customer Q&A: OMUFA Update

Recently, Reed Tech has been receiving many questions from our Pharma customers regarding the Over-The-Counter Monograph User Fee Program. As a response, we enlisted our colleague and friend, Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP to discuss these...

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EU Legacy Devices – What to Know for EUDAMED Compliance

EU Legacy Devices – What to Know for EUDAMED Compliance

As regulatory data stewards prepare medical device product datasets for EUDAMED UDI submissions, there are several scenarios to consider. A quick assessment of the requirements and your particular business portfolio strategies will likely create new questions...

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China NMPA UDI and Device Registration Basics

China NMPA UDI and Device Registration Basics

In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...

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What to Know About NDC: The Basics of National Drug Codes

What to Know About NDC: The Basics of National Drug Codes

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). Drug establishments are required to provide the FDA with a current...

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Why You Need a UDI Specialist

Why You Need a UDI Specialist

Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...

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Unique Device Identification (UDI) Update for South Korea

Unique Device Identification (UDI) Update for South Korea

Are UDI requirements in South Korea similar to other health regulators? The short answer is 'not exactly'. In this episode of Reed Tech Insights, we discuss the legislation, policy, timing and data attributes involved in the South Korean Unique Device Identification...

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OTC Monograph Fees Announced… Not so fast!

OTC Monograph Fees Announced… Not so fast!

Co-Authored by David Wilson, Sr. Account Executive, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory, LLP On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter...

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FDA Releases Long-Awaited Final Guidance on REMS in SPL Format

FDA Releases Long-Awaited Final Guidance on REMS in SPL Format

In late December 2020, the FDA issued the Final Guidance on REMS (Risk Evaluation and Mitigation Strategy) submissions in Structured Product Labeling (SPL) format. While participation is currently voluntary, and has been since September 2016, compliance with this...

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Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence

Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence

Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions. It was great to...

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Ensure Imports are Not Detained Due to FDA Non-Compliance

Ensure Imports are Not Detained Due to FDA Non-Compliance

In the final webinar of 2020, Reed Tech invited an expert attorney to discuss import compliance and how it ties into FDA compliance. David Wilson, Reed Tech, and Jennifer Diaz, Esq., Diaz Trade Law, discussed many topics ranging from compliant importation and FDA...

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UDI Assignment for Spectacle Lenses & Readers in EUDAMED

UDI Assignment for Spectacle Lenses & Readers in EUDAMED

Are makers of eyewear products subject to Unique Device Identification (UDI) requirements for compliance with EUDAMED? Recent news would indicate the answer is ‘yes’. For those manufacturers of eyewear lenses and frames, a recently posted guidance document from the EU...

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When is UDI required for drug-device combination products?

When is UDI required for drug-device combination products?

From the FDA point of view, there are some very nuanced rules about how UDI is applied to combination products. When defining a combination product, 21 CFR 3.2 explains several scenarios. As a ‘single-entity’ combination, two or more regulated components...

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Adaption and Innovation: RAPS 2020 Euro Convergence Recap

Adaption and Innovation: RAPS 2020 Euro Convergence Recap

Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. Like most of 2020, conferences and trade shows have been all about adapting. Industry has done a commendable job of adjusting and embracing what is frequently referred to as the “new normal”...

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Reed Tech Insights: What is UDI-DI and BUDI-DI?

Reed Tech Insights: What is UDI-DI and BUDI-DI?

What is UDI-DI? UDI stands for unique device identification. The labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a prescribed sequence. This includes the Device Identifier,...

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The Anatomy of a National Drug Code (NDC)

The Anatomy of a National Drug Code (NDC)

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely and universally identifies a...

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Electronic Drug Listing and Registration Guides

Electronic Drug Listing and Registration Guides

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...

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UDI Labeling (Unique Device Identification): Best Practices

UDI Labeling (Unique Device Identification): Best Practices

Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China's NMPA, South...

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Update: EUDAMED Actor Module Now Planned for December 2020

Update: EUDAMED Actor Module Now Planned for December 2020

Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The outlook is positive for...

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UDI and 21 CFR Part 11

UDI and 21 CFR Part 11

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

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Fact vs Fiction: UDI in China and Global Data Pools

Fact vs Fiction: UDI in China and Global Data Pools

Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...

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Global Data Synchronization Network

Global Data Synchronization Network

Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...

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Fact vs Fiction: GDSN Connection

Fact vs Fiction: GDSN Connection

Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction:  Most global health authorities subscribe to a GDSN data pool, therefore, UDI compliance can be achieved by a standard GDSN data pool publication. Fact:  One of the largest health authorities,...

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Reed Tech Insights: US FDA and EU EUDAMED Comparisons

Are data elements for EU EUDAMED similar to US FDA for unique device identification (UDI) submission? The short answer is, 'not exactly.' In this series of Reed Tech Insights, we take a deep-dive into the UDI data attributes of US and EU in specific areas, noting the...

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How My True-Life Medical Device Story Includes UDI

How My True-Life Medical Device Story Includes UDI

Authors: Maura Gouak, Sales Development Representative & Angela Alexandrow, Marketing Manager, Life Sciences A member of our Life Sciences team, Maura Gouak, told us about her recent experiences with a medical device. In February, she was involved in a serious car...

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Meet the Team at Reed Tech – Patti Shragher

LinkedInPatti Shragher Account Executive, Reed Tech Life SciencesPatti enjoys solving problems with technology and takes pride in strategic challenges. She consults with customers and prospects all over the globe on Reed Tech solutions for regulatory compliance,...

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Meet the Team at Reed Tech – Haley Lentz

LinkedInHaley Lentz Senior Sales Manager, Reed Tech Life SciencesSince joining the Reed Tech team in 2013, Haley has consulted with Pharmaceutical and Medical Device customers in the US and across the globe. She has first-hand experience with the complexities of FDA...

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Meet the Team at Reed Tech – Andrew Pfeifer

LinkedInAndrew Pfeifer Senior Account Executive, Reed Tech Life SciencesAndrew is an experienced guiding force for medical device professionals, having spent the last 5 years in UDI related applications. He specializes in understanding the complexities of product data...

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UDI Implementation Tips and GDSN Data Management

UDI Implementation Tips and GDSN Data Management

Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech Tracking medical devices throughout the healthcare supply chain and delivery system has proven...

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What is a GLN (Global Location Number)?

What is a GLN (Global Location Number)?

Global Location Number (GLN) A Global Location Number (GLN) is a 13 digit number that acts as a key for identifying the location, whether physical or digital, and the function or entity of a company across the supply chain. A GLN gives companies complete flexibility...

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Use GDSN to Increase Your Corporate Value

Use GDSN to Increase Your Corporate Value

What is the Global Data Synchronization Network? The GDSN is the largest online product data network. It’s a secure network that allows any agents, such as manufacturers, retailers, distributors, and wholesalers to share validated product information. Because of its...

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UK NHS eProcurement: The What, Who, Why and When

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

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UDI & GDSN Webinar – Making the most of your GUDID Data

UDI and GDSN are related, however have some distinct differences. GDSN expert Peter Alvarez of GS1 and UDI expert Gary Saner of Reed Tech discuss how medical device labelers can utilize the Global Data Synchronization Network (GDSN) to capitalize on their investment...

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GS1 UDI – How GDSN, GTIN, & GS1 Affect UDI

If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, such as “GS1,” “GTIN” and “GDSN.” But what do these terms mean and where do they fit in with UDI...

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UDI Data Security: Why it should be important to you

Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio. Confidentiality: Not all data you submit to FDA as part of a UDI...

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UDI Data Submission Case Study: Henry Schein

As Henry Schein evaluated the FDA’s requirements for Unique Device Identification (UDI), Jeff Peacock, VP of Global Quality Assurance and Regulatory Affairs, realized he and his team had a daunting task ahead of them. Henry Schein manages the distribution of...

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A Risk-Based Approach to UDI Compliance

As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data...

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UDI: How do I assign Device Identifiers?

As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all...

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FDA GUDID UDI compliance: Accuracy required

Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that...

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Handling UDI Submissions with Software-as-a-Service (SaaS)

Some medical device manufacturers seeking to comply with the FDA’s final rule on Unique Device Identification may want to turn to outside firms for help throughout the process. Others may already have the expertise in-house to handle their UDI compliance and FDA GUDID...

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GUDID Account Creation: Five Steps to Follow

When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account....

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What Your CEO Needs to Know about UDI

Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification (UDI) takes time and planning. But convincing the executives in the C-suite to allot the necessary...

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Step 1 in UDI Compliance: Assembling the Right Team

After working with a number of medical device companies to successfully submit device records to the FDA, one important piece of advice from the experts at Reed Tech is to start by gathering the right team members from the beginning. Initially, many in the medical...

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4 Questions to Ask Before Choosing a UDI Issuing Agency

As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI)...

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UDI Data Submission: Who is Responsible?

As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data record for the devices they market in the United States to the FDA’s Global Unique Device Identifier Database (GUDID). But who does the FDA consider...

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