Final Rule Represents Significant Industry Shift to Use UDIs
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
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
VeriTeQ’s Q Inside Safety Technology is an
Statements in this press release about our future expectations, including without limitation, the likelihood that VeriTeQis well positioned to continue its market penetration within breast implant and vascularport manufacturers; the likelihood 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; the likelihood that prudent manufacturers will offer non-reusable implantable devices with unique identification direct part marking, patient advocacy groups will demand it, and the inevitable product litigation will make it financially practical; constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, the ability to promptly and effectively integrate the businesses of