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Medical Device Product Data Management

Medical Device Product Data Management

UDI: A Guide to Device Identifiers

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

Reed Tech SingleSource™ for Medical Devices

NHS eProcurement Q&A

Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to...

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...

FDA Insight: UDI Data Quality

On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day...

UDI Update: New FDA GUDID Technical Documents Released

Did you know that FDA recently updated some technical documents related to GUDID submissions? On March 31, the agency sent an email to its list of GUDID email subscribers with links to an updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation...

GS1, GTIN, GDSN–What do they have to do with 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, like “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...

Data Submitted! But the UDI Journey Continues…

September 24 and the Class II UDI compliance date is past. Hopefully, you met the deadline and all of your records are now published and visible in Access GUDID, the public’s window into the GUDID database. But UDI is not over. In fact, for medical device labelers, it...

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...

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. If your company is one of those labelers that managed to comply fully with the labeling and data submission...

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. Jay Crowley also discussed the FDA’s extension for certain...

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. As we approach the Class II compliance date on September 24, 2016, it is important for industry members to understand...

Just 25 Business Days Remaining Before the Class II UDI Deadline!

Class II medical device labelers may be surprised to realize that there are only 25 business days remaining before the FDA’s Class II UDI compliance date. By September 24, 2016, all Class II devices are required to bear a UDI on the label and be entered into the FDA’s...

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