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Unique Device Identification

Unique Device Identification

UDI: A Guide to Device Identifiers

UDI Post Submission

Reed Tech UDI Solutions

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...

What’s the real cost of UDI compliance?

As we speak with Class II labelers, we often find very little thought has been given to submitting their UDI data to the FDA. Many industry members have been working for months on their UDI labeling processes but have left data submission for the very end....

Should you DIY UDI?

DIY is a growing movement. Social media platforms Pinterest and Instagram are dominated by user photos of amazing do-it-yourself home improvement projects, wedding décor and craft creations. But DIY endeavors that start with optimism and plenty of time can take an...

UDI Post-Submission Responsibilities

Summer is ticking by and only 40 working days remain until the 24 September 2016 FDA UDI compliance deadline. This means that most Class II medical device manufacturers are either on the homestretch of their UDI implementation or engaged in a fire drill to complete...

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 them an extension. Unfortunately, while certain devices are exempt from...

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...

Labeling or Data Submission, Which UDI Step Comes First?

When I speak to medical device industry members about the FDA’s requirements for submitting their UDI data to the GUDID, I am frequently told they are not worried about that aspect yet. I often hear, “We are just focusing on getting our labeling completed at this...

UDI Labeling: Pitfalls and Best Practices, Part 2 of 2

UDI labeling can be a challenge for medical device companies as they work towards compliance by the deadline. This post is part two in a two part series to help device manufacturers avoid common mistakes and implement best practices for UDI labeling. You can read part...

UDI Labeling: Pitfalls and Best Practices, Part 1 of 2

There is no doubt that UDI labeling is a hot topic among medical device manufacturers under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. With other...

FDA UDI Enforcement: 4 Things to Consider

While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not concerned about meeting the FDA’s UDI requirements by the September 24 deadline....

UDI Submission Load Testing

As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have collected their data, modified their labels and taken the other steps...

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