The FDA established the Unique Identification System (UDI) to identify medical devices sold in the US from the point of manufacturing and distribution all the way to patient use. The UDI final rule requires device labelers to: Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. […]
Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]
When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]
The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]
Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk. As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.) Signed by […]
The FDA has released a safety communication for patients with a St. Jude Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device due to batteries failing earlier than expected. These ICD and CRT-D devices are critical to the survival of patients and there have been 2 reported deaths currently due to battery failure. […]
Counterfeit drugs have become a growing issue in the Medical Manufacturing industry and as technology advances we are seeing more and more occurrences. We have addressed in previous posts the major risks in counterfeit products and how they can have a severe impact on the consumer. We rely on the integrity of the drug supply […]
The future of RFID tagging is looking more promising than ever. The RFID Journal expects the industry to reach over $5.4 Billion by 2020. A unique story we discovered on RFID Journal’s site was one that came from the operating rooms at the University of Tennessee Medical Center; they had implemented the tracking of consumable […]