Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation (“VeriTeQ”), announced today that the U.S. Food and Drug Administration (“FDA”) has released its Final Rule for Unique Device Identification (“UDI”).
The Final Rule for UDI requires all medical devices distributed in the U.S. that are intended to be used more than once and intended to undergo any form of reprocessing before each use to carry a UDI. The FDA Rule was issued in response to the passage of the FDA Safety and Innovation Act, which directed the federal agency to develop regulations that would create a UDI system for medical devices. Prior to the finalization of the FDA Final Rule, the FDA published a Proposed Rule, which included a requirement that all implantable medical devices have a “direct part marking” on the device itself rather than just labeling of disposable packaging. The direct part marking mandate for all medical devices that are implantable was revised in the FDA Final Rule to include only medical devices that are reprocessed.
Based on the Final Rule and existing relationships the Company has established with breast implant and vascular port manufacturers to identify those devices through VeriTeQ’s Q Inside Safety Technology, the Company believes it is well positioned to continue its market penetration within those categories. Furthermore, the Company believes that the changes to the Final Rule open new potential business lines in reusable or reprocessed medical devices in addition to the business opportunity in implantable medical devices.
“We believe the FDA Proposed Rule included identification of both reusable and non-reusable implantable medical devices because such identification offers an added level of patient safety and accurate device identification at the point of care or in the event of a recall, and that remains the case,” stated Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ. “Although the FDA is not requiring manufacturers to offer non-reusable implantable devices with unique identification direct part marking, we believe prudent manufacturers will do so, patient advocacy groups will demand it, and the inevitable product litigation will make it financially practical.” VeriTeQ’s Q Inside Safety Technology is an FDA cleared radio frequency identification microchip that can be used to identify an implanted medical device from outside of the body with a handheld reader.