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Achieving Compliance: Pharma Year-End Requirements

Achieving Compliance: Pharma Year-End Requirements

Each year, regulatory teams must comply with several FDA year-end deadlines. Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing...

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Status Update for Australia TGA UDI

Status Update for Australia TGA UDI

Is Australia Therapeutic Goods Administration (TGA) making progress on Unique Device Identification (UDI) requirements? The answer is yes! There are several progress milestones that have been reached. The Australia TGA website has posted a number of updates to help...

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FDA Class I Medical Device UDI Due Sept 2022

FDA Class I Medical Device UDI Due Sept 2022

Update on FDA Class I UDI On July 1, 2020 the US Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI) submissions and...

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FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? First off, what is the Global Unique Device Identification Database, also known as GUDID? It is a database that contains...

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Predicting Recalls Model and a Real-World Example

Predicting Recalls Model and a Real-World Example

Recent events are providing the opportunity to test out the concept of ‘predicting recalls’ using publicly available data. Reed Tech has been conducting a long-term project with a ‘Recall Prediction Model’. The model is being updated frequently with new medical device...

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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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Recall Prediction Model – Update

Recall Prediction Model – Update

How is the Recall Prediction Model Project progressing? In a previous post, we gave an update on the ongoing project on ‘Predicting Medical Device Recalls Using Publicly Available Data’. The hypothesis is based on using reported data on recalls to form a model to...

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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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How to Navigate Health Canada XML PM Requirements

How to Navigate Health Canada XML PM Requirements

UPDATE 5/18/2021: Phase II--full production (voluntary) will begin on June 14th. At that time, the new validation rules will go into effect and the new CV website will be available. Reed Tech kicked off 2021 with a January webinar to update customers with the most...

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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 who will soon be requiring medical device product data for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS, China NMPA, Saudi Arabia...

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Recall Prediction Model – Real World Performance

Recall Prediction Model – Real World Performance

We began a project in early 2020, asking the question “With the available history of adverse event reports, medical device recalls and in some cases, reported patient problems, can these data points be modeled to help understand if recall events are predictable in...

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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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Webinar Recording: Predicting Medical Device Recalls

Webinar Recording: Predicting Medical Device Recalls

Is predicting medical device recalls possible? We have some compelling research that indicates-yes! Did you know? We have been designing and curating an expansive database of medical device companies and products since 2016. Over time, we have been developing further...

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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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Stay Current with FDA Blanket No-Change Certification

Stay Current with FDA Blanket No-Change Certification

The fourth quarter of 2020 is fast approaching along with the Blanket No-Change deadline of December 31st. For drug manufacturers, action needs to be taken to keep product listings active before the calendar turns to 2021. What drug listings have to be updated? Every...

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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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How does a Medical Device Product Data Pool Work?

How does a Medical Device Product Data Pool Work?

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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510(k) Streamlining and Lessons Learned

510(k) Streamlining and Lessons Learned

Attending a Virtual Conference As is the rest of the world, the MDMA FDA 2020 Forum seemed to be in a place of uncertainty leading up to its scheduled occurrence last Thursday & Friday in Palo Alto, CA. However, just days before the conference, MDMA made the wise...

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COVID-19 Resources

COVID-19 Resources

As the impact of the novel coronavirus virus (COVID-19) unfolds, all of us are being challenged with adapting to new ways of working and living. We are all adjusting to social distancing, remote workplaces and restricted travel. Like many other businesses around the...

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510(k)s Make the Medical Device World Go Round

510(k)s Make the Medical Device World Go Round

Authors: Haley Lentz, Sales Manager & Rachel Benway, Product Manager, Reed Tech The medical device industry is constantly innovating new ways to treat patients in settings ranging from acute surgical care, to outpatient health centers and to home use. Of course,...

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Complaints and MDRs and Recalls, Oh My!

Complaints and MDRs and Recalls, Oh My!

Author: Rachel Benway, Product Manager, Reed Tech It was a rainy couple days in Washington, DC for the Complaints, MDRs, & Recalls Workshop hosted by AdvaMed on February 11th and 12th but that didn’t stop people from all over the world from gathering to discuss...

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Patents for Humanity – USPTO

Patents for Humanity – USPTO

Patents for Humanity is the United States Patent and Trademark Office's (USPTO) awards competition recognizing innovators who use game-changing technology to meet global humanitarian challenges. The program provides business incentives for reaching those in need....

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Voluntary Adverse Event Reporting – Get Alerts

Voluntary Adverse Event Reporting – Get Alerts

Author: Haley Lentz, Senior Sales Manager, Life Sciences Several years ago, our team met with a medical device manufacturer to review the safety and quality profile for one of their devices. During the review, the individual noticed a device problem they had not...

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The National Drug Code (NDC) 10 & 11 Digit Format

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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Medical Device Recalls – An Industry Snapshot

Medical Device Recalls – An Industry Snapshot

Author: Rachel Benway, Product Manager Reed Tech Since 2016, Reed Tech has been designing and curating the Navigator™ for Medical Devices database. At this point, it is a vast and rich source of medical device data. Using this database, we were able to run some...

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Webinar Recording: Prepare for EU and Other Global Regulators

RAPS (Regulatory Affairs Professionals Society) hosts as Reed Tech shares their expertise on the topic of 'Prepare for EU & Other Global Regulators'.  On the agenda: The known requirements of emerging regulatory channels and commercial UDI adopters Best practices...

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EU EUDAMED Delayed-What to do now

EU EUDAMED Delayed-What to do now

Author: Gary Saner, Sr Manager Information Solutions, Reed Tech The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26...

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Webinar Recording: UDI Data Management Around the Globe

Webinar Recording: UDI Data Management Around the Globe

MedTech Digital Week hosts as Reed Tech shares their expertise on the topic of 'Unique Device Identification (UDI) Data Management Around the Globe'.  On the agenda:UDI Introduction and Global LandscapeUS UDI RecapEU UDI SummaryOther Regulators and...

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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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Drug Establishment Registration: What You Need to Know

Drug Establishment Registration: What You Need to Know

Annual Registration Deadline December 31st What are Drug Establishment sites? Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import into the United States. These...

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Meet the Team at Reed Tech – Christina Wagner

Christina Wagner Account Executive, Reed Tech Life SciencesAs an Account Executive for Reed Tech, Christina focuses on the data management needs of medical device manufacturers. She connects customers with answers as they plan for regulatory data submissions to comply...

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Meet the Team Reed Tech – Maura Gouak

Maura Gouak Sales Development Representative, Reed Tech Life SciencesMaura is continually learning about real-life scenarios and data management concerns for regulatory affairs, IT and supply chain professionals. She connects information seekers with subject matter...

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Meet the Team at Reed Tech – Erin McDermott

LinkedInErin McDermott Account Executive, Reed Tech Life SciencesErin focuses on the medical device industry areas of regulatory intelligence, risk management, competitive research, and post-market surveillance. She specializes in identifying process improvements for...

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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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Shedding Light on Possible New FDA Sunscreen Regulations

Shedding Light on Possible New FDA Sunscreen Regulations

With Memorial Day Weekend marking the unofficial start of summer, millions of Americans are now enjoying warmer weather and more time outdoors. As consumers restock their beach bags and picnic baskets, the Food & Drug Administration continues to take a closer look...

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CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

Author: Carla Long, Account Executive, Life Sciences Congressional passage of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) established a new category of cannabis as “hemp”—that is, cannabis and cannabis derivatives with extremely low concentrations (no...

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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 – Connor McNelis

LinkedInConnor McNelis Sales Development Representative, Reed Tech Life SciencesConnor is currently responsible for initial outreach to prospects who want to learn more about Reed Tech solutions and services. In this role, he is continually learning about real-life...

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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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Reference Doc: FDA & EU UDI Data Elements List

Reference Doc: FDA & EU UDI Data Elements List

Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of...

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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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Blog: EU UDI-5 Things to Know for Pre-Planning

Blog: EU UDI-5 Things to Know for Pre-Planning

Medical device safety and quality around the world are being addressed in the form of common specifications and standards with variations expected country by country. The EU initiative is just the beginning. Total product...

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The 7 core elements of ISO 14971

The 7 core elements of ISO 14971

Risk Management for medical devices -- what is ISO 14971? ISO 14971 is an international standard that describes a systematic approach for medical device risk management. ISO 14971 has been recognized as a consensus standard by most regulatory agencies around the world...

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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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510(k) and Medical Device Safety News

510(k) and Medical Device Safety News

Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to...

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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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Webinar Recording: From UDI to GDSN-Are You Ready?

Webinar Recording: From UDI to GDSN-Are You Ready?

Listen to medical device data experts from Reed Tech to learn about the benefits of putting your UDI to practical use and the importance of preparing your data now for GDSN and anticipated commercial data exchange requirements. Learn how a manufacturer can...

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K2M Case Study: Tackling UDI and What Comes Next

Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people...

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Webinar Recording: NHS England eProcurement Requirements

Webinar Recording: NHS England eProcurement Requirements

Gary Saner of Reed Tech discusses what medical device companies need to do to comply with the National Health Service eProcurement requirements and how affected medical device labelers can meet the deadline. WATCH NOW TO LEARN: UK NHS eProcurement requirements and...

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NHS eProcurement Requirements, Timelines and Strategies

Join Gary Saner and John Lorenc of Reed Tech for a discussion of the UK National Health Service's (NHS) eProcurement requirements and how affected medical device labelers can comply. Read more about NHS eProcurement in this Q & A article. 

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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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Structured Product Labeling, Eh? Health Canada’s SPL Pilot

Did you know that Health Canada, the department of the Canadian government that regulates drug products, is engaged in a pilot program to introduce electronic submissions of drug product information in Structured Product Labeling (SPL) format? Officially named the...

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Drug Product Annual Reporting Periods

Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods...

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National Drug Code (NDC) Assignment Guide eBook

One of the topics our team receives frequent questions about is National Drug Codes (NDCs). How are they structured? Where do they come from? What's the difference between an NDC labeler code, product code and package code? To help industry members understand the ins...

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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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3 UDI Updates Every Device Manufacturer Should Know

In the time since the FDA’s final rule on Unique Device Identification was published on Sept. 24, 2013, much of the process to create the system to identify medical devices marketed in the United States has proceeded as expected. However, there have been several...

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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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3 Options for Managing Biologic Lot Distribution Reports (LDR)

It is not new that the FDA requires the submission of Lot Distribution Reports (LDRs) for all products marketed in the U.S. under a Biologics License Application (BLA). However, it is important for BLA holders to know that a new FDA LDR submission format will soon be...

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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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Categories

Medical Device Safety and Quality

Global Data Synchronization Network

UDI and Product Data 

Drug and Biologic Product Submissions 

COVID-19 Resources

Virtual Events

October 16, 2020 by Life Sciences Marketing

 

August 6, 2020 by Life Sciences Marketing

 

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