Search Results for: udi

HIBCC Barcodes for UDI Labeling

If you make medical devices, you are sure to be getting organized for complying with the FDA’s Unique Device Identification (UDI) program. Here at ID Technology and Greydon, we have helped a lot of companies get into compliance with the UDI rules. While a lot of the companies we’ve worked with use the GS1 barcoding […]

Just Released: FDA’s UDI Draft Guidance Document

The FDA issued a new, guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).” You may have received an email from the FDA with the announcement of the draft guide. This guide is designed to make sure your labels and data are in compliance with the UDI labeling for medical […]

Technologies for UDI Labeling

If you are in the medical devices industry, are you ready for FDA Unique Device Identification (UDI) Compliance? With the FDA’s Unique Device Identification being rolled in over the next few years, this is a good time to get prepared – there is a lot of info on the topic of UDI at the FDA’s […]

UDI and Direct Marking of Medical Devices

The FDA is distributing a draft guidance document on UDI Direct Marking of Devices and is asking for comments and suggestions within 90 of publication in the Federal Register. The FDA’s Final rule on Unique Device Identification (UDI), which was passed on September 24, 2013, mandates a system of identifying medical devices for the purpose […]

FDA Releases UDI Small Entity Compliance Guide

On August 13, 2014, the FDA released a guide to the UDI rule called “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff.” This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September 24, 2013, final rule establishing […]

UDI & Medical Device Marking – Need Help?

Need help with labeling your products or UDI compliance? Do you need to mark products that undergo sterilization? Do you need to encode more than 20 characters of data in a barcode AND don’t have enough space available? These are just some of the ways ID Technology can help medical device manufacturers with everything labeling, […]

Simplify UDI Labeling and Marking Compliance

The FDA’s new ruling on Unique Identification or UDI is very clear when it comes to the deadlines. Depending on what you manufacture or need to label/mark with a UDI, you may be facing a deadline that is less than one year away. Others will follow in sequence according to published dates. UDI compliance can […]

GS1 Accredited As Issuing Agency For UDI By U.S. FDA

For those in the Medical Device Manufacturing industry, and healthcare, this is big news. The FDA’s UDI final ruling was passed on September 24, 2013. Manufacturers of most medical devices are required to comply. (Exceptions can be found on the FDA’s website.) You will need to get your UDI issued by an FDA-accredited issuing agency. […]

The UDI Rule and Kits

Labeling a medical device to comply with the UDI rule is enough of a challenge. What if the device is part of a kit – how do you uniquely label a medical product made up of multiple items? The rule states that if a device is packaged within the immediate container of a combination product […]

FDA Issues GUDID Draft Guidance

Important news for medical device manufacturers who need to label their Class III medical devices. The FDA has issued the Global Unique Device Identification Database (GUDID) draft guidance. This document contains all of the information labelers need to know about submitting data to the database. The GUDID stores key device information, and contains only the […]