UDI Post-GUDID Publishing Webinar
UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.
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.
REMS in 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.
Data Submitted! But the UDI Journey Continues...
September 24 and the Class II UDI deadline compliance date is past. But UDI is not over. For medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.
4 Reasons to Submit REMS in SPL Now
Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS. Here are four great reasons to get start submitting REMS in SPL now.
FDA Drug Establishment Site Registration Webinar
SPL subject matter expert Jon Nolan gives an overview of the FDA's requirements for registering Drug Establishment sites. Learn More: http://www.reedtech.com/products-services/life-sciences/structur
The Anatomy of an National Drug Code (NDC)
An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete NDC is made up of a labeler code, a product code and package code.
Drug Establishment Registration Reporting Requirements and Timelines
Every electronic drug establishment registration must be renewed or updated annually between October 1 and December 31, regardless of whether there have been changes to the data.
UDI Data Submission Case Study: Henry Schein
As the Henry Schein team was faced with collecting...and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming.
Time is Up! Class II UDI Deadline Tomorrow
For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.
UDI Q&A with Jay Crowley and Gary Saner
On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.
FDA UDI Class II Extension: Does it apply to your products?
This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices.
FDA now accepting REMS in SPL format
Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient.
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.
Just 25 Business Days Remaining Before the Class II UDI Deadline!
If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?
What's the real cost of UDI compliance?
UDI team leaders should ask themselves these important questions about the total costs of their UDI data submission and management plan.
FDA UDI Enforcement
How will the FDA enforce the requirements of the UDI Final Rule? This video details what the FDA has said so far and what we can expect for UDI policing based on prior agency enforcement tactics.
Should you DIY UDI?
DIY is a growing movement. But for DIY projects, you should always use the right tool for the job and take advice from an expert. Is DIY for UDI the right approach for your organization?
UDI Post-Submission Responsibilities
UDI Exceptions, Exemptions and Extensions
As the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant...