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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...
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...
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...
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...
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...
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...
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”...
5 Key Takeaways: What You Need to Know – OTC Drug Reform & the CARES Act (Monographs & OMUFA)
For a thorough briefing on the latest with OTC Drug Reform and the CARES Act, we had a conversation with Carolina Wirth, Of Counsel, at Arnall Golden Gregory, LLP. The presentation was hosted by Gary Saner, Senior Manager, Information Solutions, Reed Tech and recorded...
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...
Saudi Arabia (SFDA) Unique Device Identification Update for Med Device Manufacturers
Background Saudi Food and Drug Authority (SFDA) issued final “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” (MDS-G34) (MDS-G34 at HIBCC) in Apri l 2019. The guidance published an update in December 2019 and a third update...
Webinar Recording: Blanket No-Change Certification-5 Steps for a Successful Submission
Register to see the recording. Thank you! The Blanket No Change Certification was introduced in 2017 when the FDA published the 'Final Labeling Rule': Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs. This rule requires any...
Reed Tech SingleSource™ for Drug Products – New Enhancements
SingleSource™ for Drug Products helps regulatory professionals manage drug product meta-data with an intuitive interface, filters, and prompts. With new enhancements soon to be released, SingleSource™ for Drug Products is even more intuitive and...
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,...
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...
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...
Webinar Recording: What You Need to Know for Med Device UDI Submission to China
5:03 Webinar Recording ExcerptTo prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI submission for specific product classes. A UDI pilot began in 2019 and has continued to the present. Published guidance is...
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...
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...
Update: EUDAMED Actor Module Now Planned for December 2020
EU EUDAMED Update 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...
Navigator for Drug Labels: Faster product label creation means faster time to market for rare-disease drug manufacturer
Katelyn Zumpino, Account Executive with the Life Sciences sales team at Reed Tech, shares a front-line perspective on the value of Reed Tech Navigator™ for Drug Labels for a rare-disease biopharmaceutical manufacturer. In working with life sciences customers, I...
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...
Webinar Recording: Updates to Health Canada’s New XML Product Monograph Launch. What you need to know and do.
Gary Saner, Sr. Manager of Information Solutions at Reed Tech Life Sciences and a subject matter expert on Drug Labeling, FDA regulations and other regulatory agencies and Jon Nolan, Associate Product Manager for Reed Tech Life Sciences Structured Product Labeling...
Your Response to the FDA Class I Medical Device UDI Delay
Update on FDA Class I UDI On July 1, 2020 the U.S. 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...
Webinar Recording: Update Your Medical Device UDI Data & Labels-This Year FDA Class I | Next Year EU MDR
3:55 Webinar Recording Excerpt When you're involved with the regulatory requirements in the medical device industry, deadlines are usually on the horizon. Join speakers from Reed Tech Life Sciences and NiceLabel® for a review of what you need to know and take action...
Webinar Recording: How Medical Device Classification and Identification Impact the Device Lifecycle
4:06 Webinar recording excerptReview this educational virtual panel discussion of 'How Medical Device Classification and Identification Impact the Device Life Cycle'. Speakers from Reed Tech, Greenlight Guru and GMDN Agency discuss the topic and take audience...
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...
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...
Webinar Recording: How to expedite FDA registration of your product during the pandemic
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 pivot from...
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,...
Impact of Product Classification & Identifiers on Medical Device Safety & Quality Research
Numerous Public Databases Abundant data is available about medical devices through the FDA including Approvals & Clearances, Adverse Events (MAUDE), Recalls, and Unique Device Identifiers (GUDID). Unfortunately, all these databases are managed and maintained...
Expedited Assistance for Regulatory Compliance Related to COVID-19
Many organizations are stepping up to innovate and transform their operations to implement goods and services needed in the battle against COVID-19. Reed Tech stands ready to help and is making mitigation of COVID-19 a priority. We remain fully operational to assist...
Balance Medical Device Risk Analysis with Internal & External Data
Author: Rachel Benway, Product ManagerLast month we held a webinar on the updates to ISO 14971 published fall of 2019 and the importance of using post-market data as part of any risk analysis process. Throughout the webinar, we performed several polls and learned...
Fighting COVID-19: Expedited FDA Product Label Approval of Hand Sanitizer and Other Products to Thwart COVID-19
The coronavirus (COVID-19) pandemic has caused disruption in the supply of alcohol-based hand sanitizers—a vital tool for hand hygiene. Traditional producers are working to increase output, and now alcohol manufacturers have an opportunity to leverage their...
Webinar Recording: Using Postmarket Data for Risk Analysis based on the Updated ISO 14971
2:27 Webinar recording excerpt How does a medical device risk become a harm? In December of 2019, ISO released a new version of their risk management regulation ISO-14971. The intent of the regulation remains unchanged but the ISO has made some changes to better...
510(k) Streamlining and Lessons Learned
Author: Erin McDermott, Account Manager Life Sciences Attending a Virtual ConferenceAs 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,...
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...
Global UDI Data Management-5 Best Practices
For Unique Device Identification (UDI) data management, there are some basics that medical device manufacturers should always keep top of mind. Here's a 3 minute run-down of Five Best Practices for Global UDI Data Management. For more information, see the...
510(k)s Make the Medical Device World Go Round
Authors: Haley Lentz, Sales Manager & Rachel Benway, Product Manager, Reed TechThe 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....
Complaints and MDRs and Recalls, Oh My!
Author: Rachel Benway, Product Manager, Reed TechIt 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...
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....
Health Canada’s New XML Product Monograph for Drug Information. What you need to know and do.
A quick look back In 2016, Health Canada announced its intention to adopt a structured format for its drug product information. With this structured format, Health Canada aims to increase transparency and accessibility of pertinent data. The move would affect product...
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...
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...
How to Search the 510(k) Database and Update Your Ineligible Predicates
Author: Rachel Benway, Product Manager, Reed Tech The FDA has placed increased attention on the 510(k) Clearance pathway over the past couple of years which included publishing multiple press announcements from FDA Commissioner Scott Gottlieb and CDRH Director Jeff...
Key Points from the Medical Device Postmarket Conference: Surveillance and Clinical
Author: Erin McDermott, Account Manager Life Sciences, Reed Tech Last week, I had the pleasure of attending the 6th Annual Medical Device Postmarket: Surveillance and Clinical Follow-Up Conference presented by Q1 Productions. This conference, or more of a workshop,...
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...
Webinar Recording: EU MDR-Best Practices for UDI Data & Product Labeling
In this free webinar, featured speakers from Reed Tech and PRISYM ID discuss what device companies will need to do to be EU MDR compliant.Who will benefit? This webinar will be suitable for individuals with the following or related job titles: Unique Device...
Reed Tech Selected by The Vision Council as the full-service solution for UDI
Reed Tech is proud to be recognized as the full-service solution for Unique Device Identification (UDI) to US FDA and other Global Regulators by The Vision CouncilHORSHAM, PA. (PRWEB) JANUARY 07, 2020 Reed Technology and Information Services Inc. (Reed Tech™),...
Survey Shows Most Are Continuing Preparation for EU EUDAMED
Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech Survey Results Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission's notice...
Webinar Recording: Understanding EU EUDAMED, Global Requirements & GDSN
Reed Tech and 1WorldSync co-present on the topic of 'Understanding EU EUDAMED, Global Requirements and GDSN'. This discussion takes a trip around the globe for UDI initiatives, timelines, and expected future challenges in implementing UDI (focusing on EU EUDAMED)....
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...
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...
Webinar Recording: CBD isn’t a drug. Or is it? Planning for the impending FDA Cannabis regulations.
3-Minute Webinar Preview We discuss: • How to navigate the current state of the CBD regulatory environment • Given what we know today, what does tomorrow look like • Ways to prepare for the impact of the FDA's ultimate ruling and regulations and minimize risk when...
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? Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a...
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...
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...
Take Steps to Avoid FDA Inactivation. Stay On Top of Your FDA Drug Registration.
When cleaning out closets at home, organization experts recommend tossing or donating anything you haven’t worn in the past year. Last month, the U.S. Food and Drug Administration (FDA) announced a major effort akin to cleaning out its “closets” – in this case, its...
Drug Establishment Registration: What You Need to Know
Registration Deadline December 31, 2020 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...
Webinar Recording: Registering EU Medical Devices & Reporting UDI Info to EUDAMED
Greenlight Guru hosts as Reed Tech shares their expertise on the topic of 'Registering EU Medical Devices and Reporting UDI info to EUDAMED'. A short excerpt: In this 60-minute webinar, you'll learn: How and when to register EU...
Executive Leaders Radio Spotlights Ethan Eisner, President of Reed Tech
Listen Above In this 10-minute interview, Ethan discusses the early stages of his career and how that informs his current role as the leader of Reed Tech. Listen above and on your local business radio station.
Reed Tech® and 1WorldSync™ to Provide Connection to European Union Database on Medical Devices (EUDAMED)
Expanded alliance to include a full-service solution including Unique Device Identifier (UDI) submission to EUDAMED Horsham, Penn. – September 10, 2019 – Reed Technology and Information Services Inc. (Reed Tech), a leading provider of data management and analytics...
A Closer Look at the FDA’s UDI Guidance: Which Convenience Kits Need UDI? Which Don’t?
Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...
Meet the Team-Christina Wagner
Meet the Team at Reed TechChristina Wagner, Account Executive, Medical Devices Q: What aspects of your job are most motivating?A: I have always loved helping others make connections to meet their specific needs. Within this role, it has been extremely rewarding to...
White Paper: What Are the EU MDR Timelines for Device Registration in EUDAMED?
What to Know about Device Registration Timing in the EU Medical Device Regulation Medical device manufacturers can start registering products in the EU EUDAMED database as of May 26, 2020, the Date of Application (DoA) for the EU Medical Device Regulation (MDR). In...
Webinar Recording: How to bring your 510(k) Research into the 21st Century
Is your team maximizing efficiency for 510(k) predicate search? In this short and informative presentation, hear about recent FDA statements concerning medical device predicates and learn key takeaways for improving search efficiency. The presenters will...
Meet the Team-Maura Gouak
Meet the Team at Reed TechMaura Gouak, Sales Development Representative, Medical Devices Q: What aspects of your job are most motivating?A: Medical device regulatory requirements for the U.S. FDA and soon, other countries, is overwhelming. Sometimes, it is challenging...
Meet the Team-Erin McDermott
Meet the Team at Reed Tech Erin McDermott, Account Executive, Medical Devices Q: What can you tell us about your current role? A: My current role at Reed Tech is a hybrid position supporting Navigator for Medical Devices across all territories. I support anyone...
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...
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...
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...
Webinar Recording: Challenges and Considerations for Building Your Own UDI Solution
Is your team evaluating UDI regulatory submissions for EU and other regions? All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a...
Meet the Team-Patti Shragher
Meet the Team at Reed TechPatti Shragher, Account Executive, Medical Devices Q: What aspects of your job are most motivating?A: Our customers are under tremendous compliance pressure. With the complexity of global regulatory requirements, the key to success is...
Meet the Team-Haley Lentz
Meet the Team at Reed TechHaley Lentz, Senior Sales Manager (Medical Devices and Pharma) Q: What aspects of your job are most motivating?A: For me, it’s so motivating to see our dreams become a reality here at Reed Tech. For example, when I started in 2013, we were...
Meet the Team-Connor McNelis
Meet the Team at Reed TechConnor McNelis, Sales Development Representative, Medical Devices Q: What is your current role at Reed Tech?A: As a Sales Development Representative, I set appointments and connect customers and prospects with Account Executives and Managers...
Meet the Team-Andrew Pfeifer
Meet the Team at Reed Tech Andrew Pfeifer, Senior Account Executive, Medical Devices Q: What aspects of your job are most motivating? A: In my role, it is critical to effectively communicate to prospects how Reed Tech can provide value to their organization....
Video: EU UDI – Q&A with Gary and John
If you are looking for useful desktop references concerning EU UDI, you have come to the right place. Reed Tech recently hosted a webinar discussion that included insights on what is currently known about EUDAMED requirements. The speakers covered detailed slides on...
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...
Webinar Recording: New Innovations Simplify Your Drug Label Research
Research and compare the most up-to-date drug label information in just a few clicks This demonstration of Reed Tech Navigator™ for Drug Labels shows how new product enhancements can help: Bolster your competitive intelligence with more detailed insights and...
Reed Tech Navigator™ for Medical Devices now includes searchable De Novos and Biologic PDFs
Navigator recently updated several functions to create even more efficiencies for users. Current and new subscribers will see these new enhancements immediately. Clearance Search510(k) Search has been changed to Clearance Search and now includes De Novos and Biologic...
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...
Reference Checklist: FDA Medical Device UDI Regulation Records, Reports, SOPs
The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a UDI placed on their product and package labels. Of equal importance, the FDA UDI regulation also requires manufactures to report medical device...
Webinar Recording: Navigator for Medical Devices – An easier way to do research
If you routinely access FDA databases, you know it can become time-consuming to pin-point exactly what you are looking for. In this webinar (originally recorded December 11, 2018 and co-hosted with Joe Hage at Medical Devices Group), you will see how Reed Tech has...
Blog: NHS England Extends eProcurement Deadline for In Vitro Diagnostic Devices: Q&A with Gary Saner
In December 2018, the National Health Service (NHS) England announced an extension to its eProcurement deadline for in-vitro diagnostic devices. Instead of being required to comply by September 2019, manufacturers now have until September 2021. I caught up with Gary...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices Supporting UDI Requirements around the Globe
HORSHAM, Pa., March 25, 2019 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech), a leader in data management and analytic services and solutions for the Life Sciences industry, announces the launch of Reed Tech SingleSource™ for Medical...
Video: What if you had a window into FDA Clearances for improved regulatory intelligence & 510(k) prep?
Want to save time doing research for 510(k) prep? See how searching for FDA Clearances for 510(k) prep can be accomplished quickly in this brief, 3 min video. Within just a few clicks, you can find new predicates for a specific or similar device or research clearances...
White Paper: Global & EU UDI Data Management Challenges & Solutions
The UDI product data submission process can be arduous without the right expertise and tools. Failures in the process can have a significant, negative impact on a medical device manufacturer’s bottom line. In light of regulatory and marketplace demands, proactive...
Blog: Did you know? Navigator for Medical Devices has made 65,000 510(k) PDFs searchable by intended use, indications for use, and device description
What is a 510(k)? In order to market a medical device, manufacturers must comply with the 510(k) section of the Food, Drug and Cosmetic Act.* This requirement states that device manufacturers must register and notify the FDA minimally 90 days in advance of their...
Video: What if you had a window into Medical Device Safety & Quality data?
When it comes to information at your fingertips, look into Navigator and see how efficient you can be. Predicates and successors to 510(k)s, guidance documents, product comparisons, industry benchmarking; it’s all here. Thanks for populating this form to view the...
Webinar Recording: Medical Device Unique Device Identification Challenges & Solutions
What do we know currently about the UDI initiative for medical devices? This webinar focuses on the current global unique device identification (UDI) activities, the trends and timelines, and the past and expected future challenges in implementing unique...
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...
Combination Product: What to Consider for both Medical Device and Drug Constituents
Authors: Gary Saner, Sr Manager Information Solutions & David Wilson, Sr Acct Exec What are the required actions when a product includes both a medical device constituent and a drug constituent? WHAT IS A COMBINATION PRODUCT? A combination product is defined...
Video: Planning for Med Device Label Changes for EU UDI
If your team is planning for the coming changes related to EU MDR/IVDR labeling, and the reporting of UDI data to EUDAMED, click below to view this brief video from our ongoing vlog series-Reed Tech Insights. Gary Saner, Sr. Manager of...
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...
Webinar Recording: How to Identify, Address and Remove the Risks of Labeling Product Recalls
Listen to the presentation as medical device labeling and device data experts from PRISYM ID and Reed Tech discuss the common causes and trends in recalls due to labeling issues. Learn about four real-life scenarios involving root causes of label recalls and how the...
Does UDI matter when it comes to Reimbursements?
Is your supply chain process prepared for reimbursement scenarios? Traditional Class I, II, III medical devices and even some ‘specialty’ accessories (like unique packaging mechanisms) need a product data management strategy that includes reimbursement considerations...
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...
Video: How Watchlists Streamline Research with Reed Tech Navigator for Medical Devices
How can product watchlists save time and effort when research is needed for medical device recalls, adverse event reports and other product comparisons? Watch this short video to learn how Navigator provides users with the power to quickly and accurately perform...
Reed Tech Insights: UDI and Class I Medical Devices
Reed Tech presented at the recent Pharma and Device Packaging and Labeling West Coast Conference in Burlingame, California. To see some quick insights, download the slides on Placing UDI on Class I Medical Device Labels and Reporting UDI Data to the FDA GUDID by...
Learn How You Can Monitor Medical Device Hazards and Review Industry Benchmarks to Mitigate Risks
To achieve market success and viability, medical device manufacturers are increasingly dependent upon regular market analysis, risk analysis, and post-surveillance data. There is a strong demand for standardized and expedited data collection to maintain market share...
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...
Don’t Wait! Blanket No Change Product Certifications – Top 6 Process Errors
If you need to submit a Blanket No Change Certification (BNCC) for your drug products this year, be aware that validation procedures are being strongly enforced by the FDA. You may encounter unforeseen errors this year that were not detected last year and need...
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...
Video: How to Efficiently Share Medical Device Product Data through GDSN
What is the Global Data Synchronization Network? The Global Data Synchronization Network (GDSN) is the electronic information highway that connects medical device manufacturers, distributors and hospital networks. It is a vital communication network designed to enable...
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...
The Clock Is Ticking! DSCSA Serialization Requirement and Certification Deadlines
By Amy Vecchione and Gary Saner, Reed Tech As part of the FDA Drug Supply Chain Security Act's (DSCSA) product tracing scheme, manufacturers and repackagers are required to place a unique product identifier, which is also known as serialization, on each package of...
All Along the Watchlist-Voluntary Adverse Event Reports and more
If you monitor medical device products, that can mean waiting to receive notifications from the FDA or other entities to surface news about reported problems or recalls. With Reed Tech Navigator™ for Medical Devices, users can activate Product Alerts to receive...
Don’t Forget: Blanket No-Change Certification – November 28 Serialization Requirement
An important notice to manufacturers and re-packagers of prescription drug products issued recently from the FDA website. You may recall that in 2017, the FDA introduced a change requiring registered drug establishments to submit a "blanket no-change certification”...
Webinar Recording: Are You Prepared for the Annual Blanket No Change Certification Reporting Period?
Reporting Deadline: December 31, 2020 Jon Nolan, Associate Product Manager, Reed Tech Life Sciences Team, discusses the annual No Change Certification submission requirements for drug product listings and the steps needed...
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...
Webinar Recording: From UDI to GDSN-Evolving Medical Device Data
Join John Lorenc from Reed Tech, Becky Aldhizer from STERIS Corporation, and Scott Brown from 1WorldSync as they discuss commercial data exchange efforts for medical device product data through GDSN. WATCH NOW FOR: The basic...
Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels
Horsham, Penn. – July 9, 2018 – Reed Technology and Information Services Inc. (Reed Tech), a provider of high-quality data management and analytics solutions for the life sciences industry, announces the launch of Reed Tech...
FDA Drug Listing: When You Need a Manual Override
One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents...
Webinar Recording: FDA Drug Listing Requirements for Manufacturers & Distributors
Join Jon Nolan and Gary Saner of Reed Tech to learn about FDA requirements for Electronic Drug Listing and their application to Contract Manufacturing (CMO) and Private Label Distributor (PLD) organizations. WATCH NOW FOR: Electronic Drug Listing Environment History...
Structured Product Monograph: Health Canada Plants its SPL Flag
In 2016, Health Canada announced its intention to adopt a structured format for its drug product monographs. In harmonization with international data standards, Canada selected the HL7 Structured Product Labeling (SPL) authoring...
Video: Deeper Market Research with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical DevicesA whole new way to conduct deeper market research with safety and quality data. Learn more at ReedTech.com/Navigator
FDA Changes for Private Label Distributors and Contract Manufacturing Organizations
The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they...
Webinar Recording: FDA Expectations for Biologic Lot Distribution Reporting
David Wilson of Reed Tech discusses FDA requirements for Biologic Lot Distribution Reports (LDR) and what industry has learned three years since the electronic SPL mandate. WATCH NOW TO LEARN: LDR background and...
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...
Business Development Insights from Medical Device Safety and Quality Data
More big data is now available at our fingertips than ever before. Leading companies in every industry are harnessing the power of data analytics to drive informed decisions across their business processes. Medical device manufacturers, in particular, should be making...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices, Advancing the Ability to Manage and Share Device Product Data
Reed Tech, a LexisNexis® company and leading provider of data management and analytics solutions for the life sciences industry, introduces Reed Tech SingleSource for Medical Devices, a data management tool built specifically to meet the needs of medical device...
A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync
Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission...
NHS eProcurement Q&A
Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to MedDevice@ReedTech.com
Reed Tech Navigator™ for Medical Devices Recognized with a 2017 Connectiv Innovation Award
Easily accessible medical device data analytics now available with Navigator Horsham, Penn— Reed Tech®, a LexisNexis® company, announced today that Reed Tech Navigator for Medical Devices has been recognized with a 2017 Connectiv Innovation Award in the category of...
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.
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...
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...
GDSN for NHS eProcurement and Buyer Data Requests Webinar Reed Tech 1WorldSync
Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™
The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data with trading partners through the Global Data Synchronization Network (GDSN). This will allow device...
Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices
Horsham, Penn. – April 10, 2017 – Reed Technology and Information Services Inc. (Reed Tech), a leader in data analytics and information services for the Life Sciences industry, announces the launch of Reed Tech Navigator™ for Medical Devices. Navigator...
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...
GDUFA Self-Identification: What Generic Companies Need to Know
Reed Tech subject matter expert Jon Nolan talks GDUFA and Self-Identification during a webinar March 8, 2017.
UDI & GDSN Webinar – Making the most of your GUDID Data
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 in GUDID data.
Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync
HORSHAM, PA - February 8, 2017 - Reed Tech, a provider of data management solutions for the life sciences industry, and 1WorldSync, the world’s largest global content exchange network, have entered into a collaborative agreement to enable more robust product content...
FDA’s Electronic Drug Listing Requirements for Manufacturers
If your company manufactures drug products for distribution in the United States, you probably know that you are required to register your establishment site(s) annually with FDA in Structured Product Labeling (SPL) format. Many manufacturers are unaware, however,...
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...
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 FDA’s UDI...
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...
REMS in Structured Product Labeling SPL Webinar
SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling format.
FDA Electronic Drug Establishment and Registration Webinar Recording
SPL subject matter expert Jon Nolan gives an overview of the FDA's requirements for registering Drug Establishment sites. Learn More: https://www.reedtech.com/products-services/life-sciences/structured-product-labeling-management Questions? Contact SPL@ReedTech.com
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...
UDI: Best Practices in Data Management, Barcoding and Direct Marking
UDI experts Gary Saner (Reed Tech) and Michael Barron (Domino) discuss best practices for medical device labelers seeking to comply with the FDA's Unique Device Identification mandate.
UDI Pitfalls & Best Practices for Labeling and Data Management
UDI experts Gary Saner (Reed Tech) and Lee Patty (NiceLabel) discuss UDI problems encountered by medical device labelers and the strategies employed to overcome them.
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...
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product Labeling (SPL) for their GUDID submissions....
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...
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...
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...
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...
Electronic Lot Distribution Reports Are More Complex Than You Think
New FDA regulations for submitting electronic Lot Distribution Reports (LDRs) went into effect June 10, 2015. They apply to all companies that market products in the U.S. under a Biologics License Application (BLA). Some companies must submit their first reports in...
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....
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...
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...
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...
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...
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...
One Step in FDA UDI Compliance: The Dun & Bradstreet DUNS Number
In preparing for compliance with the U.S. Food and Drug Administration's final rule requiring Unique Device Identifiers (UDIs) for medical devices distributed in the U.S., there are a number of steps that device manufacturers should be aware of before submitting data...
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